Green Laser Photocoagulation Study in Proliferative Diabetic Retinopathy

Study Overview
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Brief Summary
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To Demonstrate that indigenous green laser produces similar treatment effect on the retina when compared with already available green laser.

Detailed Description
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Proliferative Diabetic Retinopathy is ocular pathology in poor glycaemic controlled Diabetic patient Characterized by micro-vascular pathology with capillary closure in the retina leading to hypoxia of tissue there by formation of immature vessels to provide better oxygenation of retinal tissue. In this randomized double blinded study a convenient sample size of 24 eyes assigned to compare indigenously developed green laser with already available green laser.

Official Title
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Comparative Study of Indigenous Green Laser With Already Available Green Laser in Proliferative Diabetic Retinopathy

Conditions
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Diabetic Retinopathy

Intervention / Treatment
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* Device: Green Laser (Aurolas, Aurolab)
* Device: Green Laser (Iridex)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients more than 18 years of age Eyes with proliferative diabetic retinopathy requiring laser photocoagulation Exclusion Criteria: Eyes with media opacities not allowing proper fundus photography or adequate laser photocoagulation Patients requiring more than two sessions of laser photocoagulation Patients who had undergone previous laser photocoagulation Patients who had undergone any previous vitreo-retinal surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Aurolab Green Laser | Device: Green Laser (Aurolas, Aurolab)<br>* Green laser developed by Aurolab<br>* Other names: Aurolas;|
| Active Comparator: 2<br>Available Green Laser | Device: Green Laser (Iridex)<br>* Already available green laser<br>* Other names: Iridex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pigmentation of burn |  | 2 months, 4 months, 6 months post laser | 
| Lateral spread of burn |  | 2 months, 4 months, 6 months post laser | 
| Regression of new vessels |  | 2 months, 4 months, 6 months post laser | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Choroidal detachment |  | 2 months, 4 months, 6 months post laser | 
| Retinal detachment |  | 2 months, 4 months, 6 months post laser | 
| Tractional retinal detachment |  | 2 months, 4 months, 6 months post laser | 
| Bruch's membrane rupture |  | 2 months, 4 months, 6 months post laser | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Retina, Retinal Diseases, Retinal Vessels, Laser Coagulation