Diabetic Retinopathy Clinical Trial
Official title:
The Effect of Laser Pan-retinal Photocoagulation on Macular Pigment Optical Density in Cases With Diabetic Retinopathy
Verified date | May 2017 |
Source | Afyon Kocatepe University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
It has been hypothesized that thermal damage of laser pan-retinal photocoagulation may affect macular pigment as well as inner layer cells in the retina, so it was aimed to investigate possible effect of conventional laser pan-retinal photocoagulation on macular pigment optical density in diabetic retinopathy patients without macular edema and pathology in this study.
Status | Completed |
Enrollment | 36 |
Est. completion date | July 12, 2016 |
Est. primary completion date | June 8, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Best corrected visual acuity (BCVA) logMAR =0.4 - Newly diagnosis of PDR and initiation of conventional laser PRP treatment - Between the ages of 40 and 65 years (40=age=65) Exclusion Criteria: - Corneal scarring, cataract or intravitreal hemorrhage that prevents appearance of the fundus - Presence of macular pathologies such as AMD or choroidopathy - Presence of macular edema or NVE in the macular area - Detection of macular fluid or edema in OCT or FFA - Previous laser PRP treatments - Focal and / or grid photocoagulation requirements - Previous refractive or vitreoretinal surgery - Spherical refractive error = ±6.00 D or cylinder refractive error = ±3.00 D - 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Afyon Kocatepe University Hospital |
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change macular pigment optical density from baseline at 6 months | Macular pigment optical density measures were repeated and recorded at 1st, 2nd, 3rd month before laser treatments and 6th month | 1 month and 3 months | |
Secondary | Correlation analysis between macular pigment optical density and panretinal laser photocoagulation parameters during 6 months | The correlations between macular pigment optical density outcomes and panretinal laser photocoagulation parameters (total energy, total area, total shots, total duration) were evaluated for 6 months | 6 months |
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