Implantation of Capsular Tension Ring in Primary Angle Closure Patients With Zonular Laxity or Dialysis
Primary Purpose
Glaucoma, Angle-Closure
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Capsular tension ring implantation
No capsular tension ring implantation
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma focused on measuring angle closure, zonular laxity, zonular dialysis, lens subluxation, capsular tension ring, efficacy, safety
Eligibility Criteria
Inclusion Criteria:
- Age: 45-79 years old
- Continuous cases diagnosed with AACC, PACS, PAC and PACG in glaucoma department of Beijing Tongren Hospital from October 1st, 2022 to December 31th, 2024 and undergo phacoemulsification lens extraction and intraocular lens implantation combined with goniosynechialysis
- Wrinkling of the anterior capsule during manual continuous circular capsulorhexis (CCC) but without infolding of peripheral capsule or visualization of the capsular equator, or, wrinkling of the anterior capsule during manual capsulorhexis and combined with visualization of capsular equator and infolding of peripheral capsule ≤ 4 clocks (lens subluxation)
- The eye of each subject that meet the inclusion criteria is included and if both eyes meet the inclusion criteria, the first eye that undergo the surgery is included
Exclusion Criteria:
- Past history of intraocular surgeries including trabeculectomy, peripheral iridotomy, glaucoma valve implantation, vitrectomy, and so on
- Past history of laser peripheral iridotomy or iridoplasty
- Past history of ocular trauma or signs referring to ocular trauma
- Ocular diseases that may cause zonulopathy, including choroidal detachment, retinal detachment, ciliary body detachment, intraocular tumor and so on
- Lens related secondary glaucoma, including spherophakia, Marfan syndrome, homocystinuria and son on
- Other secondary angle closure glaucoma, including neovascular glaucoma, iritis related secondary glaucoma and so on
- Visualization of capsular equator and infolding of peripheral capsule > 4 clocks during the surgery
- Anterior or posterior capsule rupture during the surgery which makes it impossible for CTR implantation
Sites / Locations
- Beijing Tongren Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
With capsular tension ring implantation
Without capsular tension ring implantation
Arm Description
We performed phacoemulsification lens extraction and intraocular lens implantation with capsular tension ring implantation combined with goniosynechialysis.
We performed phacoemulsification lens extraction and intraocular lens implantation without capsular tension ring implantation combined with goniosynechialysis.
Outcomes
Primary Outcome Measures
Spherical equivalent
Sphere +1/2 cylinder obtained from subjective refraction
Spherical equivalent
Sphere +1/2 cylinder obtained from subjective refraction
Spherical equivalent
Sphere +1/2 cylinder obtained from subjective refraction
Spherical equivalent
Sphere +1/2 cylinder obtained from subjective refraction
Spherical equivalent
Sphere +1/2 cylinder obtained from subjective refraction
Area of anterior capsulorhexis
Area of anterior capsulorhexis measured using slit-lamp photography
Area of anterior capsulorhexis
Area of anterior capsulorhexis measured using slit-lamp photography
Area of anterior capsulorhexis
Area of anterior capsulorhexis measured using slit-lamp photography
Area of anterior capsulorhexis
Area of anterior capsulorhexis measured using slit-lamp photography
Area of anterior capsulorhexis
Area of anterior capsulorhexis measured using slit-lamp photography
Assessment of posterior capsular opacification
Assessment of posterior capsular opacification using slit-lamp photography
Assessment of posterior capsular opacification
Assessment of posterior capsular opacification using slit-lamp photography
Assessment of posterior capsular opacification
Assessment of posterior capsular opacification using slit-lamp photography
Assessment of posterior capsular opacification
Assessment of posterior capsular opacification using slit-lamp photography
Assessment of posterior capsular opacification
Assessment of posterior capsular opacification using slit-lamp photography
The extent of iris-trabecular contact
The extent of iris-trabecular contact assessed by gonioscopy
The extent of iris-trabecular contact
The extent of iris-trabecular contact assessed by gonioscopy
The extent of iris-trabecular contact
The extent of iris-trabecular contact assessed by gonioscopy
The extent of iris-trabecular contact
The extent of iris-trabecular contact assessed by gonioscopy
The extent of iris-trabecular contact
The extent of iris-trabecular contact assessed by gonioscopy
The extent of peripheral anterior synechia
The extent of peripheral anterior synechia assessed by gonioscopy
The extent of peripheral anterior synechia
The extent of peripheral anterior synechia assessed by gonioscopy
The extent of peripheral anterior synechia
The extent of peripheral anterior synechia assessed by gonioscopy
The extent of peripheral anterior synechia
The extent of peripheral anterior synechia assessed by gonioscopy
The extent of peripheral anterior synechia
The extent of peripheral anterior synechia assessed by gonioscopy
Corneal thickness
Corneal thickness obtained by IOL Master 700
Central anterior chamber depth
Central anterior chamber depth obtained by IOL Master 700
Lens thickness
Lens thickness obtained by IOL Master 700
Axial Length
Axial Length obtained by IOL Master 700
Refractive prediction error
Refractive prediction error obtained by IOL Master 700
Anterior chamber depth
Anterior chamber depth obtained by anterior segment optical coherence tomography
Anterior chamber depth
Anterior chamber depth obtained by anterior segment optical coherence tomography
Anterior chamber depth
Anterior chamber depth obtained by anterior segment optical coherence tomography
Anterior chamber depth
Anterior chamber depth obtained by anterior segment optical coherence tomography
Anterior chamber depth
Anterior chamber depth obtained by anterior segment optical coherence tomography
Anterior chamber depth
Anterior chamber depth obtained by anterior segment optical coherence tomography
Angle opening distance
Angle opening distance obtained by anterior segment optical coherence tomography
Angle opening distance
Angle opening distance obtained by anterior segment optical coherence tomography
Angle opening distance
Angle opening distance obtained by anterior segment optical coherence tomography
Angle opening distance
Angle opening distance obtained by anterior segment optical coherence tomography
Angle opening distance
Angle opening distance obtained by anterior segment optical coherence tomography
Angle opening distance
Angle opening distance obtained by anterior segment optical coherence tomography
Trabecular-iris space area
Trabecular-iris space area obtained by anterior segment optical coherence tomography
Trabecular-iris space area
Trabecular-iris space area obtained by anterior segment optical coherence tomography
Trabecular-iris space area
Trabecular-iris space area obtained by anterior segment optical coherence tomography
Trabecular-iris space area
Trabecular-iris space area obtained by anterior segment optical coherence tomography
Trabecular-iris space area
Trabecular-iris space area obtained by anterior segment optical coherence tomography
Trabecular-iris space area
Trabecular-iris space area obtained by anterior segment optical coherence tomography
Trabecular-iris angle
Trabecular-iris angle obtained by anterior segment optical coherence tomography
Trabecular-iris angle
Trabecular-iris angle obtained by anterior segment optical coherence tomography
Trabecular-iris angle
Trabecular-iris angle obtained by anterior segment optical coherence tomography
Trabecular-iris angle
Trabecular-iris angle obtained by anterior segment optical coherence tomography
Trabecular-iris angle
Trabecular-iris angle obtained by anterior segment optical coherence tomography
Trabecular-iris angle
Trabecular-iris angle obtained by anterior segment optical coherence tomography
Anterior chamber width
Anterior chamber width obtained by anterior segment optical coherence tomography
Anterior chamber width
Anterior chamber width obtained by anterior segment optical coherence tomography
Anterior chamber width
Anterior chamber width obtained by anterior segment optical coherence tomography
Anterior chamber width
Anterior chamber width obtained by anterior segment optical coherence tomography
Anterior chamber width
Anterior chamber width obtained by anterior segment optical coherence tomography
Anterior chamber width
Anterior chamber width obtained by anterior segment optical coherence tomography
Iris thickness
Iris thickness obtained by anterior segment optical coherence tomography
Iris thickness
Iris thickness obtained by anterior segment optical coherence tomography
Iris thickness
Iris thickness obtained by anterior segment optical coherence tomography
Iris thickness
Iris thickness obtained by anterior segment optical coherence tomography
Iris thickness
Iris thickness obtained by anterior segment optical coherence tomography
Iris thickness
Iris thickness obtained by anterior segment optical coherence tomography
Iris cross-sectional area
Iris cross-sectional area obtained by anterior segment optical coherence tomography
Iris cross-sectional area
Iris cross-sectional area obtained by anterior segment optical coherence tomography
Iris cross-sectional area
Iris cross-sectional area obtained by anterior segment optical coherence tomography
Iris cross-sectional area
Iris cross-sectional area obtained by anterior segment optical coherence tomography
Iris cross-sectional area
Iris cross-sectional area obtained by anterior segment optical coherence tomography
Iris cross-sectional area
Iris cross-sectional area obtained by anterior segment optical coherence tomography
Iris curvature
Iris curvature obtained by anterior segment optical coherence tomography
Iris curvature
Iris curvature obtained by anterior segment optical coherence tomography
Iris curvature
Iris curvature obtained by anterior segment optical coherence tomography
Iris curvature
Iris curvature obtained by anterior segment optical coherence tomography
Iris curvature
Iris curvature obtained by anterior segment optical coherence tomography
Iris curvature
Iris curvature obtained by anterior segment optical coherence tomography
Lens thickness
Lens thickness obtained by anterior segment optical coherence tomography
Lens thickness
Lens thickness obtained by anterior segment optical coherence tomography
Lens thickness
Lens thickness obtained by anterior segment optical coherence tomography
Lens thickness
Lens thickness obtained by anterior segment optical coherence tomography
Lens thickness
Lens thickness obtained by anterior segment optical coherence tomography
Lens thickness
Lens thickness obtained by anterior segment optical coherence tomography
Lens vault
Lens vault obtained by anterior segment optical coherence tomography
Lens vault
Lens vault obtained by anterior segment optical coherence tomography
Lens vault
Lens vault obtained by anterior segment optical coherence tomography
Lens vault
Lens vault obtained by anterior segment optical coherence tomography
Lens vault
Lens vault obtained by anterior segment optical coherence tomography
Lens vault
Lens vault obtained by anterior segment optical coherence tomography
The distance between intraocular lens and the posterior capsular
The distance between intraocular lens and the posterior capsular obtained by CASIA2 anterior segment optical coherence tomography
The distance between intraocular lens and the posterior capsular
The distance between intraocular lens and the posterior capsular obtained by CASIA2 anterior segment optical coherence tomography
The distance between intraocular lens and the posterior capsular
The distance between intraocular lens and the posterior capsular obtained by CASIA2 anterior segment optical coherence tomography
The distance between intraocular lens and the posterior capsular
The distance between intraocular lens and the posterior capsular obtained by CASIA2 anterior segment optical coherence tomography
The distance between intraocular lens and the posterior capsular
The distance between intraocular lens and the posterior capsular obtained by CASIA2 anterior segment optical coherence tomography
Intraocular lens inclination angle
Intraocular lens inclination angle obtained by CASIA2 anterior segment optical coherence tomography
Intraocular lens inclination angle
Intraocular lens inclination angle obtained by CASIA2 anterior segment optical coherence tomography
Intraocular lens inclination angle
Intraocular lens inclination angle obtained by CASIA2 anterior segment optical coherence tomography
Intraocular lens inclination angle
Intraocular lens inclination angle obtained by CASIA2 anterior segment optical coherence tomography
Intraocular lens inclination angle
Intraocular lens inclination angle obtained by CASIA2 anterior segment optical coherence tomography
Effective intraocular lens position
Effective intraocular lens position obtained by CASIA2 anterior segment optical coherence tomography
Effective intraocular lens position
Effective intraocular lens position obtained by CASIA2 anterior segment optical coherence tomography
Effective intraocular lens position
Effective intraocular lens position obtained by CASIA2 anterior segment optical coherence tomography
Effective intraocular lens position
Effective intraocular lens position obtained by CASIA2 anterior segment optical coherence tomography
Effective intraocular lens position
Effective intraocular lens position obtained by CASIA2 anterior segment optical coherence tomography
The distance between ciliary body and the equator of lens at 3 o'clock position
The distance between ciliary body and the equator of lens at 3 o'clock position obtained by ultrasound biomicroscopy
The distance between ciliary body and the equator of lens at 6 o'clock position
The distance between ciliary body and the equator of lens at 6 o'clock position obtained by ultrasound biomicroscopy
The distance between ciliary body and the equator of lens at 9 o'clock position
The distance between ciliary body and the equator of lens at 9 o'clock position obtained by ultrasound biomicroscopy
The distance between ciliary body and the equator of lens at 12 o'clock position
The distance between ciliary body and the equator of lens at 12 o'clock position obtained by ultrasound biomicroscopy
Incidence of complications
Incidence of complications including posterior capsular opacification (PCO), IOL tilt, capsule contraction syndrome, et al.
Incidence of complications
Incidence of complications including PCO, IOL tilt, capsule contraction syndrome, et al.
Incidence of complications
Incidence of complications including PCO, IOL tilt, capsule contraction syndrome, et al.
Incidence of complications
Incidence of complications including PCO, IOL tilt, capsule contraction syndrome, et al.
Secondary Outcome Measures
Presenting visual acuity
Presenting visual acuity with or without glasses
Presenting visual acuity
Presenting visual acuity with or without glasses
Presenting visual acuity
Presenting visual acuity with or without glasses
Presenting visual acuity
Presenting visual acuity with or without glasses
Presenting visual acuity
Presenting visual acuity with or without glasses
Presenting visual acuity
Presenting visual acuity with or without glasses
Presenting visual acuity
Presenting visual acuity with or without glasses
Best corrected visual acuity
Visual acuity with refractive correction
Best corrected visual acuity
Visual acuity with refractive correction
Best corrected visual acuity
Visual acuity with refractive correction
Best corrected visual acuity
Visual acuity with refractive correction
Best corrected visual acuity
Visual acuity with refractive correction
Intraocular pressure
Intraocular pressure obtained by non-contact tonometer
Intraocular pressure
Intraocular pressure obtained by non-contact tonometer
Intraocular pressure
Intraocular pressure obtained by non-contact tonometer
Intraocular pressure
Intraocular pressure obtained by non-contact tonometer
Intraocular pressure
Intraocular pressure obtained by non-contact tonometer
Intraocular pressure
Intraocular pressure obtained by non-contact tonometer
Intraocular pressure
Intraocular pressure obtained by non-contact tonometer
Number of anti-glaucoma medications
Number of anti-glaucoma medications
Number of anti-glaucoma medications
Number of anti-glaucoma medications
Number of anti-glaucoma medications
Number of anti-glaucoma medications
Number of anti-glaucoma medications
Number of anti-glaucoma medications
Number of anti-glaucoma medications
Number of anti-glaucoma medications
Vertical cup-to-disc ratio
Vertical cup-to-disc ratio evaluated by fundus photography
Vertical cup-to-disc ratio
Vertical cup-to-disc ratio evaluated by fundus photography
Vertical cup-to-disc ratio
Vertical cup-to-disc ratio evaluated by fundus photography
Vertical cup-to-disc ratio
Vertical cup-to-disc ratio evaluated by fundus photography
Full Information
NCT ID
NCT05542290
First Posted
September 3, 2022
Last Updated
March 6, 2023
Sponsor
Beijing Tongren Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05542290
Brief Title
Implantation of Capsular Tension Ring in Primary Angle Closure Patients With Zonular Laxity or Dialysis
Official Title
Implantation of Capsular Tension Ring in Primary Angle Closure Patients With Zonular Laxity or Dialysis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2023 (Anticipated)
Primary Completion Date
October 1, 2025 (Anticipated)
Study Completion Date
October 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tongren Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Primary angle closure glaucoma (PACG) is the main type of glaucoma in China, which includes acute and chronic PACG. According to the International Society of Geographical and Epidemiological Ophthalmology (ISGEO), this spectrum of disease is divided into acute angle closure crisis (AACC), primary angle closure suspect (PACS), primary angle closure (PAC) and PACG. Previous researchers have reported that with the wider use of lens extraction and intraocular lens (IOL) implantation combined with anti-glaucoma surgery in the treatment of PAC and PACG, the prevalence of zonular laxity or dialysis in primary angle closure disease (PACD) was found to be relatively high. In one of the studies performed by the investigators, the proportion of zonular laxity or dialysis was 46.2%, significantly higher than that in the age-related cataract patients (control group), which was 6.0%. In PACD patients with zonular laxity or dialysis, whether or not should the investigators implant capsular tension ring (CTR), the efficacy and safety of CTR implantation, and if there is any difference in the prevalence of complications during and after surgery between patients with and without CTR implantation remain unclear. The purpose of this study was to investigate the efficacy and safety of CTR implantation in PACD patients with zonular laxity and zonular dialysis ≤ 4 clocks.
Detailed Description
Patients with PACD who are scheduled to have phacoemulsification and IOL implantation combined with goniosynechialysis are recruited. All recruited patients attended comprehensive eye examinations and interviews. Past history of ocular and systemic diseases, family and personal history, history of ocular trauma and surgery were interviewed. And the patients underwent ophthalmic examinations including visual acuity tests (presenting visual acuity [PVA] and best-corrected visual acuity [BCVA]), subjective refraction, intraocular pressure (IOP) measurements, slit-lamp examination, fundus photography, gonioscopy, ocular biometry using IOL Master 700, ultrasound biomicroscopy, anterior segment optical coherence tomography (ASOCT) imaging. All patients provide informed consent for inclusion in the study.
All surgery procedures were performed by the same surgeons (CYQ) using the same standard operation procedure. All patients use the same type of foldable IOL calculated using SRK/T formula. During the surgery, patients with wrinkling of the anterior capsule (multiple sinusoidal folds were formed) during continuous curvilineal capsulorhexis (CCC) at the needle or forceps tip but without infolding of peripheral capsule or visualisation of the capsular equator during the cortical or nuclear removal, or, wrinkling of the anterior capsule during CCC with infolding of peripheral capsule and visualisation of the capsular equator ≤ 4 clocks of range during the cortical or nuclear removal, were finally included in the study and randomly assigned (using a random-number table generated by SAS) with equal probability to either CTR group (with CTR implantation during the surgery) and control group (without CTR implantation during the surgery). All patients included in the CTR group use the same type of CTR. The investigators recorded the complications during the surgery including vitreous prolapse, hyphema, vitreous hemorrhage, damage of iris and lens capsule, et al.
Postoperatively, all patients received similar routine medication comprising topical prednisolone acetate (six times a day for 1 week and tapered down by 1 time every week), topical levofloxacin hydrochloride (four times a day for 1 month), and Tobramycin and Dexamethasone Eye Ointment (1 time every night for 1 month).
Postoperative examinations were performed at 1 day, 1 week, 1 months, 3 months, 6 months and 12 months. During the follow-up visits, a complete ophthalmic examination was performed including PVA, BCVA, subjective refraction, non-contact IOP measurement, slit-lamp examination, slit-lamp photography after pupil dilation, ASOCT, gonioscopy, and fundus imaging.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Angle-Closure
Keywords
angle closure, zonular laxity, zonular dialysis, lens subluxation, capsular tension ring, efficacy, safety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
156 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
With capsular tension ring implantation
Arm Type
Experimental
Arm Description
We performed phacoemulsification lens extraction and intraocular lens implantation with capsular tension ring implantation combined with goniosynechialysis.
Arm Title
Without capsular tension ring implantation
Arm Type
Other
Arm Description
We performed phacoemulsification lens extraction and intraocular lens implantation without capsular tension ring implantation combined with goniosynechialysis.
Intervention Type
Procedure
Intervention Name(s)
Capsular tension ring implantation
Intervention Description
Capsular tension ring implantation during phacoemulsification lens extraction and intraocular lens implantation combined with goniosynechialysis in included angle closure patients.
Intervention Type
Procedure
Intervention Name(s)
No capsular tension ring implantation
Intervention Description
No capsular tension ring implantation during phacoemulsification lens extraction and intraocular lens implantation combined with goniosynechialysis in included angle closure patients.
Primary Outcome Measure Information:
Title
Spherical equivalent
Description
Sphere +1/2 cylinder obtained from subjective refraction
Time Frame
baseline
Title
Spherical equivalent
Description
Sphere +1/2 cylinder obtained from subjective refraction
Time Frame
1 month after the surgery
Title
Spherical equivalent
Description
Sphere +1/2 cylinder obtained from subjective refraction
Time Frame
3 months after the surgery
Title
Spherical equivalent
Description
Sphere +1/2 cylinder obtained from subjective refraction
Time Frame
6 months after the surgery
Title
Spherical equivalent
Description
Sphere +1/2 cylinder obtained from subjective refraction
Time Frame
12 months after the surgery
Title
Area of anterior capsulorhexis
Description
Area of anterior capsulorhexis measured using slit-lamp photography
Time Frame
1 week after the surgery
Title
Area of anterior capsulorhexis
Description
Area of anterior capsulorhexis measured using slit-lamp photography
Time Frame
1 month after the surgery
Title
Area of anterior capsulorhexis
Description
Area of anterior capsulorhexis measured using slit-lamp photography
Time Frame
3 months after the surgery
Title
Area of anterior capsulorhexis
Description
Area of anterior capsulorhexis measured using slit-lamp photography
Time Frame
6 months after the surgery
Title
Area of anterior capsulorhexis
Description
Area of anterior capsulorhexis measured using slit-lamp photography
Time Frame
12 months after the surgery
Title
Assessment of posterior capsular opacification
Description
Assessment of posterior capsular opacification using slit-lamp photography
Time Frame
1 week after the surgery
Title
Assessment of posterior capsular opacification
Description
Assessment of posterior capsular opacification using slit-lamp photography
Time Frame
1 month after the surgery
Title
Assessment of posterior capsular opacification
Description
Assessment of posterior capsular opacification using slit-lamp photography
Time Frame
3 months after the surgery
Title
Assessment of posterior capsular opacification
Description
Assessment of posterior capsular opacification using slit-lamp photography
Time Frame
6 months after the surgery
Title
Assessment of posterior capsular opacification
Description
Assessment of posterior capsular opacification using slit-lamp photography
Time Frame
12 months after the surgery
Title
The extent of iris-trabecular contact
Description
The extent of iris-trabecular contact assessed by gonioscopy
Time Frame
baseline
Title
The extent of iris-trabecular contact
Description
The extent of iris-trabecular contact assessed by gonioscopy
Time Frame
1 month after the surgery
Title
The extent of iris-trabecular contact
Description
The extent of iris-trabecular contact assessed by gonioscopy
Time Frame
3 months after the surgery
Title
The extent of iris-trabecular contact
Description
The extent of iris-trabecular contact assessed by gonioscopy
Time Frame
6 months after the surgery
Title
The extent of iris-trabecular contact
Description
The extent of iris-trabecular contact assessed by gonioscopy
Time Frame
12 months after the surgery
Title
The extent of peripheral anterior synechia
Description
The extent of peripheral anterior synechia assessed by gonioscopy
Time Frame
baseline
Title
The extent of peripheral anterior synechia
Description
The extent of peripheral anterior synechia assessed by gonioscopy
Time Frame
1 month after the surgery
Title
The extent of peripheral anterior synechia
Description
The extent of peripheral anterior synechia assessed by gonioscopy
Time Frame
3 months after the surgery
Title
The extent of peripheral anterior synechia
Description
The extent of peripheral anterior synechia assessed by gonioscopy
Time Frame
6 months after the surgery
Title
The extent of peripheral anterior synechia
Description
The extent of peripheral anterior synechia assessed by gonioscopy
Time Frame
12 months after the surgery
Title
Corneal thickness
Description
Corneal thickness obtained by IOL Master 700
Time Frame
baseline
Title
Central anterior chamber depth
Description
Central anterior chamber depth obtained by IOL Master 700
Time Frame
baseline
Title
Lens thickness
Description
Lens thickness obtained by IOL Master 700
Time Frame
baseline
Title
Axial Length
Description
Axial Length obtained by IOL Master 700
Time Frame
baseline
Title
Refractive prediction error
Description
Refractive prediction error obtained by IOL Master 700
Time Frame
baseline
Title
Anterior chamber depth
Description
Anterior chamber depth obtained by anterior segment optical coherence tomography
Time Frame
baseline
Title
Anterior chamber depth
Description
Anterior chamber depth obtained by anterior segment optical coherence tomography
Time Frame
1 week after the surgery
Title
Anterior chamber depth
Description
Anterior chamber depth obtained by anterior segment optical coherence tomography
Time Frame
1 month after the surgery
Title
Anterior chamber depth
Description
Anterior chamber depth obtained by anterior segment optical coherence tomography
Time Frame
3 months after the surgery
Title
Anterior chamber depth
Description
Anterior chamber depth obtained by anterior segment optical coherence tomography
Time Frame
6 months after the surgery
Title
Anterior chamber depth
Description
Anterior chamber depth obtained by anterior segment optical coherence tomography
Time Frame
12 months after the surgery
Title
Angle opening distance
Description
Angle opening distance obtained by anterior segment optical coherence tomography
Time Frame
baseline
Title
Angle opening distance
Description
Angle opening distance obtained by anterior segment optical coherence tomography
Time Frame
1 week after the surgery
Title
Angle opening distance
Description
Angle opening distance obtained by anterior segment optical coherence tomography
Time Frame
1 month after the surgery
Title
Angle opening distance
Description
Angle opening distance obtained by anterior segment optical coherence tomography
Time Frame
3 months after the surgery
Title
Angle opening distance
Description
Angle opening distance obtained by anterior segment optical coherence tomography
Time Frame
6 months after the surgery
Title
Angle opening distance
Description
Angle opening distance obtained by anterior segment optical coherence tomography
Time Frame
12 months after the surgery
Title
Trabecular-iris space area
Description
Trabecular-iris space area obtained by anterior segment optical coherence tomography
Time Frame
baseline
Title
Trabecular-iris space area
Description
Trabecular-iris space area obtained by anterior segment optical coherence tomography
Time Frame
1 week after the surgery
Title
Trabecular-iris space area
Description
Trabecular-iris space area obtained by anterior segment optical coherence tomography
Time Frame
1 month after the surgery
Title
Trabecular-iris space area
Description
Trabecular-iris space area obtained by anterior segment optical coherence tomography
Time Frame
3 months after the surgery
Title
Trabecular-iris space area
Description
Trabecular-iris space area obtained by anterior segment optical coherence tomography
Time Frame
6 months after the surgery
Title
Trabecular-iris space area
Description
Trabecular-iris space area obtained by anterior segment optical coherence tomography
Time Frame
12 months after the surgery
Title
Trabecular-iris angle
Description
Trabecular-iris angle obtained by anterior segment optical coherence tomography
Time Frame
baseline
Title
Trabecular-iris angle
Description
Trabecular-iris angle obtained by anterior segment optical coherence tomography
Time Frame
1 week after the surgery
Title
Trabecular-iris angle
Description
Trabecular-iris angle obtained by anterior segment optical coherence tomography
Time Frame
1 month after the surgery
Title
Trabecular-iris angle
Description
Trabecular-iris angle obtained by anterior segment optical coherence tomography
Time Frame
3 months after the surgery
Title
Trabecular-iris angle
Description
Trabecular-iris angle obtained by anterior segment optical coherence tomography
Time Frame
6 months after the surgery
Title
Trabecular-iris angle
Description
Trabecular-iris angle obtained by anterior segment optical coherence tomography
Time Frame
12 months after the surgery
Title
Anterior chamber width
Description
Anterior chamber width obtained by anterior segment optical coherence tomography
Time Frame
baseline
Title
Anterior chamber width
Description
Anterior chamber width obtained by anterior segment optical coherence tomography
Time Frame
1 week after the surgery
Title
Anterior chamber width
Description
Anterior chamber width obtained by anterior segment optical coherence tomography
Time Frame
1 month after the surgery
Title
Anterior chamber width
Description
Anterior chamber width obtained by anterior segment optical coherence tomography
Time Frame
3 months after the surgery
Title
Anterior chamber width
Description
Anterior chamber width obtained by anterior segment optical coherence tomography
Time Frame
6 months after the surgery
Title
Anterior chamber width
Description
Anterior chamber width obtained by anterior segment optical coherence tomography
Time Frame
12 months after the surgery
Title
Iris thickness
Description
Iris thickness obtained by anterior segment optical coherence tomography
Time Frame
baseline
Title
Iris thickness
Description
Iris thickness obtained by anterior segment optical coherence tomography
Time Frame
1 week after the surgery
Title
Iris thickness
Description
Iris thickness obtained by anterior segment optical coherence tomography
Time Frame
1 month after the surgery
Title
Iris thickness
Description
Iris thickness obtained by anterior segment optical coherence tomography
Time Frame
3 months after the surgery
Title
Iris thickness
Description
Iris thickness obtained by anterior segment optical coherence tomography
Time Frame
6 months after the surgery
Title
Iris thickness
Description
Iris thickness obtained by anterior segment optical coherence tomography
Time Frame
12 months after the surgery
Title
Iris cross-sectional area
Description
Iris cross-sectional area obtained by anterior segment optical coherence tomography
Time Frame
baseline
Title
Iris cross-sectional area
Description
Iris cross-sectional area obtained by anterior segment optical coherence tomography
Time Frame
1 week after the surgery
Title
Iris cross-sectional area
Description
Iris cross-sectional area obtained by anterior segment optical coherence tomography
Time Frame
1 month after the surgery
Title
Iris cross-sectional area
Description
Iris cross-sectional area obtained by anterior segment optical coherence tomography
Time Frame
3 months after the surgery
Title
Iris cross-sectional area
Description
Iris cross-sectional area obtained by anterior segment optical coherence tomography
Time Frame
6 months after the surgery
Title
Iris cross-sectional area
Description
Iris cross-sectional area obtained by anterior segment optical coherence tomography
Time Frame
12 months after the surgery
Title
Iris curvature
Description
Iris curvature obtained by anterior segment optical coherence tomography
Time Frame
baseline
Title
Iris curvature
Description
Iris curvature obtained by anterior segment optical coherence tomography
Time Frame
1 week after the surgery
Title
Iris curvature
Description
Iris curvature obtained by anterior segment optical coherence tomography
Time Frame
1 month after the surgery
Title
Iris curvature
Description
Iris curvature obtained by anterior segment optical coherence tomography
Time Frame
3 months after the surgery
Title
Iris curvature
Description
Iris curvature obtained by anterior segment optical coherence tomography
Time Frame
6 months after the surgery
Title
Iris curvature
Description
Iris curvature obtained by anterior segment optical coherence tomography
Time Frame
12 months after the surgery
Title
Lens thickness
Description
Lens thickness obtained by anterior segment optical coherence tomography
Time Frame
baseline
Title
Lens thickness
Description
Lens thickness obtained by anterior segment optical coherence tomography
Time Frame
1 week after the surgery
Title
Lens thickness
Description
Lens thickness obtained by anterior segment optical coherence tomography
Time Frame
1 month after the surgery
Title
Lens thickness
Description
Lens thickness obtained by anterior segment optical coherence tomography
Time Frame
3 months after the surgery
Title
Lens thickness
Description
Lens thickness obtained by anterior segment optical coherence tomography
Time Frame
6 months after the surgery
Title
Lens thickness
Description
Lens thickness obtained by anterior segment optical coherence tomography
Time Frame
12 months after the surgery
Title
Lens vault
Description
Lens vault obtained by anterior segment optical coherence tomography
Time Frame
baseline
Title
Lens vault
Description
Lens vault obtained by anterior segment optical coherence tomography
Time Frame
1 week after the surgery
Title
Lens vault
Description
Lens vault obtained by anterior segment optical coherence tomography
Time Frame
1 month after the surgery
Title
Lens vault
Description
Lens vault obtained by anterior segment optical coherence tomography
Time Frame
3 months after the surgery
Title
Lens vault
Description
Lens vault obtained by anterior segment optical coherence tomography
Time Frame
6 months after the surgery
Title
Lens vault
Description
Lens vault obtained by anterior segment optical coherence tomography
Time Frame
12 months after the surgery
Title
The distance between intraocular lens and the posterior capsular
Description
The distance between intraocular lens and the posterior capsular obtained by CASIA2 anterior segment optical coherence tomography
Time Frame
1 week after the surgery
Title
The distance between intraocular lens and the posterior capsular
Description
The distance between intraocular lens and the posterior capsular obtained by CASIA2 anterior segment optical coherence tomography
Time Frame
1 month after the surgery
Title
The distance between intraocular lens and the posterior capsular
Description
The distance between intraocular lens and the posterior capsular obtained by CASIA2 anterior segment optical coherence tomography
Time Frame
3 months after the surgery
Title
The distance between intraocular lens and the posterior capsular
Description
The distance between intraocular lens and the posterior capsular obtained by CASIA2 anterior segment optical coherence tomography
Time Frame
6 months after the surgery
Title
The distance between intraocular lens and the posterior capsular
Description
The distance between intraocular lens and the posterior capsular obtained by CASIA2 anterior segment optical coherence tomography
Time Frame
12 months after the surgery
Title
Intraocular lens inclination angle
Description
Intraocular lens inclination angle obtained by CASIA2 anterior segment optical coherence tomography
Time Frame
1 week after the surgery
Title
Intraocular lens inclination angle
Description
Intraocular lens inclination angle obtained by CASIA2 anterior segment optical coherence tomography
Time Frame
1 month after the surgery
Title
Intraocular lens inclination angle
Description
Intraocular lens inclination angle obtained by CASIA2 anterior segment optical coherence tomography
Time Frame
3 months after the surgery
Title
Intraocular lens inclination angle
Description
Intraocular lens inclination angle obtained by CASIA2 anterior segment optical coherence tomography
Time Frame
6 months after the surgery
Title
Intraocular lens inclination angle
Description
Intraocular lens inclination angle obtained by CASIA2 anterior segment optical coherence tomography
Time Frame
12 months after the surgery
Title
Effective intraocular lens position
Description
Effective intraocular lens position obtained by CASIA2 anterior segment optical coherence tomography
Time Frame
1 week after the surgery
Title
Effective intraocular lens position
Description
Effective intraocular lens position obtained by CASIA2 anterior segment optical coherence tomography
Time Frame
1 month after the surgery
Title
Effective intraocular lens position
Description
Effective intraocular lens position obtained by CASIA2 anterior segment optical coherence tomography
Time Frame
3 months after the surgery
Title
Effective intraocular lens position
Description
Effective intraocular lens position obtained by CASIA2 anterior segment optical coherence tomography
Time Frame
6 months after the surgery
Title
Effective intraocular lens position
Description
Effective intraocular lens position obtained by CASIA2 anterior segment optical coherence tomography
Time Frame
12 months after the surgery
Title
The distance between ciliary body and the equator of lens at 3 o'clock position
Description
The distance between ciliary body and the equator of lens at 3 o'clock position obtained by ultrasound biomicroscopy
Time Frame
baseline
Title
The distance between ciliary body and the equator of lens at 6 o'clock position
Description
The distance between ciliary body and the equator of lens at 6 o'clock position obtained by ultrasound biomicroscopy
Time Frame
baseline
Title
The distance between ciliary body and the equator of lens at 9 o'clock position
Description
The distance between ciliary body and the equator of lens at 9 o'clock position obtained by ultrasound biomicroscopy
Time Frame
baseline
Title
The distance between ciliary body and the equator of lens at 12 o'clock position
Description
The distance between ciliary body and the equator of lens at 12 o'clock position obtained by ultrasound biomicroscopy
Time Frame
baseline
Title
Incidence of complications
Description
Incidence of complications including posterior capsular opacification (PCO), IOL tilt, capsule contraction syndrome, et al.
Time Frame
1 month after the surgery
Title
Incidence of complications
Description
Incidence of complications including PCO, IOL tilt, capsule contraction syndrome, et al.
Time Frame
3 months after the surgery
Title
Incidence of complications
Description
Incidence of complications including PCO, IOL tilt, capsule contraction syndrome, et al.
Time Frame
6 months after the surgery
Title
Incidence of complications
Description
Incidence of complications including PCO, IOL tilt, capsule contraction syndrome, et al.
Time Frame
12 months after the surgery
Secondary Outcome Measure Information:
Title
Presenting visual acuity
Description
Presenting visual acuity with or without glasses
Time Frame
baseline
Title
Presenting visual acuity
Description
Presenting visual acuity with or without glasses
Time Frame
1 day after the surgery
Title
Presenting visual acuity
Description
Presenting visual acuity with or without glasses
Time Frame
1 week after the surgery
Title
Presenting visual acuity
Description
Presenting visual acuity with or without glasses
Time Frame
1 month after the surgery
Title
Presenting visual acuity
Description
Presenting visual acuity with or without glasses
Time Frame
3 months after the surgery
Title
Presenting visual acuity
Description
Presenting visual acuity with or without glasses
Time Frame
6 months after the surgery
Title
Presenting visual acuity
Description
Presenting visual acuity with or without glasses
Time Frame
12 months after the surgery
Title
Best corrected visual acuity
Description
Visual acuity with refractive correction
Time Frame
baseline
Title
Best corrected visual acuity
Description
Visual acuity with refractive correction
Time Frame
1 month after the surgery
Title
Best corrected visual acuity
Description
Visual acuity with refractive correction
Time Frame
3 months after the surgery
Title
Best corrected visual acuity
Description
Visual acuity with refractive correction
Time Frame
6 months after the surgery
Title
Best corrected visual acuity
Description
Visual acuity with refractive correction
Time Frame
12 months after the surgery
Title
Intraocular pressure
Description
Intraocular pressure obtained by non-contact tonometer
Time Frame
baseline
Title
Intraocular pressure
Description
Intraocular pressure obtained by non-contact tonometer
Time Frame
1 day after the surgery
Title
Intraocular pressure
Description
Intraocular pressure obtained by non-contact tonometer
Time Frame
1 week after the surgery
Title
Intraocular pressure
Description
Intraocular pressure obtained by non-contact tonometer
Time Frame
1 month after the surgery
Title
Intraocular pressure
Description
Intraocular pressure obtained by non-contact tonometer
Time Frame
3 months after the surgery
Title
Intraocular pressure
Description
Intraocular pressure obtained by non-contact tonometer
Time Frame
6 months after the surgery
Title
Intraocular pressure
Description
Intraocular pressure obtained by non-contact tonometer
Time Frame
12 months after the surgery
Title
Number of anti-glaucoma medications
Description
Number of anti-glaucoma medications
Time Frame
1 week after the surgery
Title
Number of anti-glaucoma medications
Description
Number of anti-glaucoma medications
Time Frame
1 month after the surgery
Title
Number of anti-glaucoma medications
Description
Number of anti-glaucoma medications
Time Frame
3 months after the surgery
Title
Number of anti-glaucoma medications
Description
Number of anti-glaucoma medications
Time Frame
6 months after the surgery
Title
Number of anti-glaucoma medications
Description
Number of anti-glaucoma medications
Time Frame
12 months after the surgery
Title
Vertical cup-to-disc ratio
Description
Vertical cup-to-disc ratio evaluated by fundus photography
Time Frame
baseline
Title
Vertical cup-to-disc ratio
Description
Vertical cup-to-disc ratio evaluated by fundus photography
Time Frame
1 month after the surgery
Title
Vertical cup-to-disc ratio
Description
Vertical cup-to-disc ratio evaluated by fundus photography
Time Frame
6 months after the surgery
Title
Vertical cup-to-disc ratio
Description
Vertical cup-to-disc ratio evaluated by fundus photography
Time Frame
12 months after the surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age: 45-79 years old
Continuous cases diagnosed with AACC, PACS, PAC and PACG in glaucoma department of Beijing Tongren Hospital from October 1st, 2022 to December 31th, 2024 and undergo phacoemulsification lens extraction and intraocular lens implantation combined with goniosynechialysis
Wrinkling of the anterior capsule during manual continuous circular capsulorhexis (CCC) but without infolding of peripheral capsule or visualization of the capsular equator, or, wrinkling of the anterior capsule during manual capsulorhexis and combined with visualization of capsular equator and infolding of peripheral capsule ≤ 4 clocks (lens subluxation)
The eye of each subject that meet the inclusion criteria is included and if both eyes meet the inclusion criteria, the first eye that undergo the surgery is included
Exclusion Criteria:
Past history of intraocular surgeries including trabeculectomy, peripheral iridotomy, glaucoma valve implantation, vitrectomy, and so on
Past history of laser peripheral iridotomy or iridoplasty
Past history of ocular trauma or signs referring to ocular trauma
Ocular diseases that may cause zonulopathy, including choroidal detachment, retinal detachment, ciliary body detachment, intraocular tumor and so on
Lens related secondary glaucoma, including spherophakia, Marfan syndrome, homocystinuria and son on
Other secondary angle closure glaucoma, including neovascular glaucoma, iritis related secondary glaucoma and so on
Visualization of capsular equator and infolding of peripheral capsule > 4 clocks during the surgery
Anterior or posterior capsule rupture during the surgery which makes it impossible for CTR implantation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chunyan Qiao, M.D.
Phone
86-17610678637
Email
chunyan_qiao@163.com
Facility Information:
Facility Name
Beijing Tongren Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunyan Qiao, M.D.
Phone
86017610678637
Email
chunyan_qiao@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Implantation of Capsular Tension Ring in Primary Angle Closure Patients With Zonular Laxity or Dialysis
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