Changes of Macular Pigment and Parameters of Eyes After YAG Laser Treatment in Cases With Capsule Opacification
Primary Purpose
Posterior Capsule Opacification, Retinal Degeneration, Retinal Detachment
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nd: YAG laser posterior capsulotomy
Sponsored by
About this trial
This is an interventional treatment trial for Posterior Capsule Opacification focused on measuring Posterior Capsule Opacification, Macular Pigment Optical Density, Anterior Chamber Parameters, Nd: YAG Laser Posterior Capsulotomy, Posterior Capsulotomy, Cystoid Macular Edema, Choroidal Thickness
Eligibility Criteria
Inclusion Criteria:
- Best-corrected visual acuity (BCVA) logMAR <0.3
- Duration at least 2 years after cataract surgery
- Between the ages of 45 and 65 years (45≤age≤65)
Exclusion Criteria:
- Corneal scarring, diffuse posterior PCO or intravitreal hemorrhage that prevents appearance of the fundus
- Occluded angle by gonioscopy (grade 0, narrow angle, grade I, grade II)
- Presence of macular or peripheral retinal pathologies or choroidopathy
- High risk for RD
- Presence of macular edema in the macular area
- Detection of macular fluid or edema in OCT
- Active intraocular inflammation
- Previous laser PRP, Nd: YAG laser posterior capsulotomy, laser iridotomy or selective laser trabeculoplasty interventions
- Previous iridectomy, glaucoma or vitreoretinal surgery
- Glass intraocular lens
- Spherical refractive error ≥ ±6.00 D or cylinder refractive error ≥ ±3.00 D
- Inadequate stability of the eye
- Systemic diseases that may affect the choroidal blood flow such as cardiological diseases
- Current use of carotenoid supplementation
- Changing eating habits
- Gastrointestinal diseases that could cause disturbance of dietary absorption
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nd: YAG laser posterior capsulotomy
Arm Description
Posterior capsulotomy was performed by using Nd: YAG laser and macular pigment optical density, intra ocular pressure, choroidal thickness, macular thickness and anterior chamber parameters were measured before Nd: YAG laser, at 1 week, 1 month and 2 months
Outcomes
Primary Outcome Measures
Changes of Foveal and Pericentral Pigment Optical Density (Log Unit) From Baseline at 2 Months
Foveal and pericentral pigment optical density was measured by using color perimetry technique and recorded as log unit before Nd: YAG laser posterior capsulotomy, at 1 week, 1 month and 2 months
Changes of Subfoveal, Temporal and Nasal Choroidal Thicknesses (Micrometer) From Baseline at 2 Months
Subfoveal, temporal and nasal choroidal thicknesses were measured by using enhanced-deep imaging optical coherence tomography and recorded as micrometer before Nd: YAG laser posterior capsulotomy, at 1 week, at 1-month and at 2-month
Changes of Anterior Chamber Depth (Millimeter) From Baseline at 2 Months
Anterior chamber depth was measured by using anterior segment module optical coherence tomography and recorded as millimeter before Nd: YAG laser posterior capsulotomy, at 1 week, at 1-month and at 2-month
Changes of Iridocorneal Angle From Baseline at 2 Months
Iridocorneal angle was measured by using anterior segment module optical coherence tomography and recorded as millimeter before Nd: YAG laser posterior capsulotomy, at 1 week, at 1-month and 2-month
Secondary Outcome Measures
Changes of Central Macular Thicknesses (Micrometer) From Baseline at 2 Months
Full Information
NCT ID
NCT03321253
First Posted
October 15, 2017
Last Updated
July 28, 2019
Sponsor
Afyon Kocatepe University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03321253
Brief Title
Changes of Macular Pigment and Parameters of Eyes After YAG Laser Treatment in Cases With Capsule Opacification
Official Title
Changes of Macular Pigment Optical Density and Parameters After Nd: YAG Laser Posterior Capsulotomy in Cases With Posterior Capsule Opacification
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
October 23, 2015 (Actual)
Primary Completion Date
April 12, 2016 (Actual)
Study Completion Date
May 16, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Afyon Kocatepe University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
It has been hypothesized that potential effects of laser Nd: YAG laser posterior capsulotomy may affect macular pigment as well as choroidal thickness, macular thickness and anterior chamber parameters, so it was aimed to investigate possible effects of Nd: YAG laser posterior capsulotomy on macular pigment optical density, choroidal thickness, macular thickness and anterior chamber parameters in cases with posterior capsule opacification in this study.
Detailed Description
This clinical trial was conducted following the principles of the Declaration of Helsinki. The local authorized clinical trials ethics committee approved the protocol and consent forms (Afyon Kocatepe University Clinical Trials Ethics Committee, 2011-KAEK-2 2017/172). Between 2015 and 2016, 38 pseudophakic participants were enrolled in this study. After providing information to patients about the disease and treatment, patients predicted to show adherence to treatment, were enrolled in the study.
Detailed ophthalmological examinations of all subjects were performed prior to Nd: YAG laser posterior capsulotomy intervention. Anterior chamber parameters of cases with PCO were measured Measurements of IOP, anterior chamber parameters, visual acuity, Slit-lamp, gonioscopy and fundus examinations, and measurements of central macular thickness (CMT), choroidal thicknesses (CTs), and MPOD were performed after maximal pupil dilatation.
Proposed procedure, including risks, benefits, and alternatives were discussed with all subjects, and all participants signed of informed consent form.
Choroidal thicknesses were recorded as subfoveal CT (SCT), nasal CT (NCT) and temporal CT (TCT).
MPOD measurements were subsequently made by using luminance differential thresholds test. After measurements a refractive surgery specialist carried out Nd: YAG laser posterior capsulotomy interventions to patients who were decided to applying Nd:YAG laser capsulotomy.
All examinations and measurements were repeated and recorded at 1st week, 1st and 2nd month.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posterior Capsule Opacification, Retinal Degeneration, Retinal Detachment, Anterior Chamber Angle Congestion, Macula Edema, Macular Pigmentation, Choroid Disease
Keywords
Posterior Capsule Opacification, Macular Pigment Optical Density, Anterior Chamber Parameters, Nd: YAG Laser Posterior Capsulotomy, Posterior Capsulotomy, Cystoid Macular Edema, Choroidal Thickness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
sequential self-controlled clinical trial
Masking
None (Open Label)
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nd: YAG laser posterior capsulotomy
Arm Type
Experimental
Arm Description
Posterior capsulotomy was performed by using Nd: YAG laser and macular pigment optical density, intra ocular pressure, choroidal thickness, macular thickness and anterior chamber parameters were measured before Nd: YAG laser, at 1 week, 1 month and 2 months
Intervention Type
Device
Intervention Name(s)
Nd: YAG laser posterior capsulotomy
Other Intervention Name(s)
Tango Laserex
Intervention Description
Nd: YAG laser posterior capsulotomy
Primary Outcome Measure Information:
Title
Changes of Foveal and Pericentral Pigment Optical Density (Log Unit) From Baseline at 2 Months
Description
Foveal and pericentral pigment optical density was measured by using color perimetry technique and recorded as log unit before Nd: YAG laser posterior capsulotomy, at 1 week, 1 month and 2 months
Time Frame
2 months
Title
Changes of Subfoveal, Temporal and Nasal Choroidal Thicknesses (Micrometer) From Baseline at 2 Months
Description
Subfoveal, temporal and nasal choroidal thicknesses were measured by using enhanced-deep imaging optical coherence tomography and recorded as micrometer before Nd: YAG laser posterior capsulotomy, at 1 week, at 1-month and at 2-month
Time Frame
2 months
Title
Changes of Anterior Chamber Depth (Millimeter) From Baseline at 2 Months
Description
Anterior chamber depth was measured by using anterior segment module optical coherence tomography and recorded as millimeter before Nd: YAG laser posterior capsulotomy, at 1 week, at 1-month and at 2-month
Time Frame
2 months
Title
Changes of Iridocorneal Angle From Baseline at 2 Months
Description
Iridocorneal angle was measured by using anterior segment module optical coherence tomography and recorded as millimeter before Nd: YAG laser posterior capsulotomy, at 1 week, at 1-month and 2-month
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Changes of Central Macular Thicknesses (Micrometer) From Baseline at 2 Months
Time Frame
2 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Best-corrected visual acuity (BCVA) logMAR <0.3
Duration at least 2 years after cataract surgery
Between the ages of 45 and 65 years (45≤age≤65)
Exclusion Criteria:
Corneal scarring, diffuse posterior PCO or intravitreal hemorrhage that prevents appearance of the fundus
Occluded angle by gonioscopy (grade 0, narrow angle, grade I, grade II)
Presence of macular or peripheral retinal pathologies or choroidopathy
High risk for RD
Presence of macular edema in the macular area
Detection of macular fluid or edema in OCT
Active intraocular inflammation
Previous laser PRP, Nd: YAG laser posterior capsulotomy, laser iridotomy or selective laser trabeculoplasty interventions
Previous iridectomy, glaucoma or vitreoretinal surgery
Glass intraocular lens
Spherical refractive error ≥ ±6.00 D or cylinder refractive error ≥ ±3.00 D
Inadequate stability of the eye
Systemic diseases that may affect the choroidal blood flow such as cardiological diseases
Current use of carotenoid supplementation
Changing eating habits
Gastrointestinal diseases that could cause disturbance of dietary absorption
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Changes of Macular Pigment and Parameters of Eyes After YAG Laser Treatment in Cases With Capsule Opacification
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