Comparative Study of Indigenous Green Laser With Already Available Green Laser in Proliferative Diabetic Retinopathy
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Aurolab
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Pigmentation of burn
Study Overview
Brief Summary
To Demonstrate that indigenous green laser produces similar treatment effect on the retina when compared with already available green laser.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
1
Aurolab Green Laser
Intervention: Green Laser (Aurolas, Aurolab) (Device)
2
Available Green Laser
Intervention: Green Laser (Iridex) (Device)
Outcomes
Primary Outcomes
Pigmentation of burn
Time Frame: 2 months, 4 months, 6 months post laser
Lateral spread of burn
Time Frame: 2 months, 4 months, 6 months post laser
Regression of new vessels
Time Frame: 2 months, 4 months, 6 months post laser
Secondary Outcomes
- 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)
- Choroidal detachment(2 months, 4 months, 6 months post laser)