Incidence of Complete Posterior Vitreous Detachment After Trabeculectomy.
Primary Purpose
Posterior Vitreous Detachment
Status
Not yet recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Wide-field optical coherence tomography
Sponsored by
About this trial
This is an interventional diagnostic trial for Posterior Vitreous Detachment focused on measuring posterior vitreous detachment, trabeculectomy, vitreomacular interface
Eligibility Criteria
Inclusion Criteria:
- Primary open angle glaucoma or primary angle closure glaucoma
- Age 18-65 years
- Could be taken the wide-field OCT images
- Written informed consent
Exclusion Criteria:
- History of intraocular inflammation or infection
- History of ocular trauma or head trauma
- History of intraocular surgery such as intravitreal drug injection and cataract surgery
- History of vitreoretinal diseases such as diabetic retinopathy, retinal vascular occlusion and age-related macular degeneration
- History of laser treatment including laser capsulotomy and retinal photocoagulation
- High myopia; spherical equivalence >4 diopters
- Complete PVD was detected before the enrollment
Sites / Locations
- Khon Kaen University
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Glaucoma patients who was scheduled for trabeculectomy
Arm Description
Wide-field OCT was performed 1-2 weeks before the trabeculectomy. The OCT was done postoperatively at 1 month, 3 months, 6 months and 12 months after surgery.
Outcomes
Primary Outcome Measures
Incidence of PVD
complete PVD
Secondary Outcome Measures
The incidence of VMI abnormalities
Vitreomacular traction, Epimacular membrane, Peripheral retinal break
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04726267
Brief Title
Incidence of Complete Posterior Vitreous Detachment After Trabeculectomy.
Official Title
Incidence of Complete Posterior Vitreous Detachment After Trabeculectomy.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2021 (Anticipated)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Khon Kaen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Intraocular surgery could induce vitreous degeneration and posterior vitreous detachment (PVD). Vitreomacular interface (VMI) abnormalities usually are caused by abnormal PVD, vitreoschisis and partial-thickness PVD. Furthermore, the PVD could induce the peripheral break. The incidence of peripheral break and epimacular membrane (EMM) after pneumatic retinopexy were 11.7% and 4-11%, respectively. Although multiple intravitreal anti-vascular endothelial growth factor (anti-VEGF) injections induced PVD of 5.6%, but peripheral break was reported as only 0.67%.
The most common intraocular surgery is cataract surgery. From the literature review, many methods were used to detect the PVD after phacoemulsification. The former studies used indirect ophthalmoscopy and ocular ultrasound for diagnosis of PVD. The later studies used the optical coherence tomography (OCT) for PVD detection. The OCT device had higher effectiveness in evaluation of the posterior segment, then it can detect post-phacoemulsification PVD more and early than previous studies. Ivastinovic et al demonstrated 59.2% of patients had PVD at 1 month after phacoemulsification, and increased up to 71.4% at 3 months. The incidence of rhegmatogenous retinal detachment (RRD) after phacoemulsification is gradually increased with time. The accumulative risk of RRD was increased from 0.27% at 1 year to 1.27% at 20 years after phacoemulsification.
Detailed Description
Trabeculectomy is one of the intraocular surgery. Although the volume of intraocular fluid use during the trabeculectomy was much less than used during phacoemulsification, trabeculectomy also could induce the PVD and it's sequelae such as VMI abnormalities. Because the baseline visual acuity of glaucoma patients who were indicated for trabeculectomy usually quite poor, so the sequelae of PVD can cause more visual loss. The incidence of PVD after trabeculectomy has never been published before and nowadays no standard guideline for retinal examination or screening after surgery. Furthermore, Tsukahara et al introduced wide-field OCT-based PVD classification. The new OCT device with higher technology will be useful in PVD detection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posterior Vitreous Detachment
Keywords
posterior vitreous detachment, trabeculectomy, vitreomacular interface
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Glaucoma patients who was scheduled for trabeculectomy
Arm Type
Other
Arm Description
Wide-field OCT was performed 1-2 weeks before the trabeculectomy. The OCT was done postoperatively at 1 month, 3 months, 6 months and 12 months after surgery.
Intervention Type
Device
Intervention Name(s)
Wide-field optical coherence tomography
Intervention Description
Merged 4 images of wide-field optical coherence tomography, 2 images of vertical scan and 2 images of horizontal scan.
Primary Outcome Measure Information:
Title
Incidence of PVD
Description
complete PVD
Time Frame
12 months
Secondary Outcome Measure Information:
Title
The incidence of VMI abnormalities
Description
Vitreomacular traction, Epimacular membrane, Peripheral retinal break
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Primary open angle glaucoma or primary angle closure glaucoma
Age 18-65 years
Could be taken the wide-field OCT images
Written informed consent
Exclusion Criteria:
History of intraocular inflammation or infection
History of ocular trauma or head trauma
History of intraocular surgery such as intravitreal drug injection and cataract surgery
History of vitreoretinal diseases such as diabetic retinopathy, retinal vascular occlusion and age-related macular degeneration
History of laser treatment including laser capsulotomy and retinal photocoagulation
High myopia; spherical equivalence >4 diopters
Complete PVD was detected before the enrollment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suthasinee Sinawat, MD
Phone
+66 81 5454594
Email
ssuthasinee@kku.ac.th
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suthasinee Sinawat, MD
Organizational Affiliation
KKU Eye Center, Department of Ophthalmology, Faculty of Medicine, Khon Kaen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Khon Kaen University
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suthasinee Sinawat, MD
Phone
+66 815454594
Email
ssuthasinee@kku.ac.th
First Name & Middle Initial & Last Name & Degree
Sukhumal Thanapaisal, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Incidence of Complete Posterior Vitreous Detachment After Trabeculectomy.
We'll reach out to this number within 24 hrs