Green Laser Photocoagulation Study in Proliferative Diabetic Retinopathy

Condition(s) targeted: Diabetic Retinopathy

Intervention: Photocoagulation (Procedure)

Phase: Phase 3

Status: Completed

Sponsored by: Aurolab

Official(s) and/or principal investigator(s):
Chandra Mohan, MS, Principal Investigator, Affiliation: Arvind Eye Hospital, Madurai
Dhananjay Shukla, MS, Principal Investigator, Affiliation: Aravind Eye Hospital
Naresh Babu, MS, FNB, Principal Investigator, Affiliation: Aravind Eye Hospital

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

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

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Pigmentation of burn

Lateral spread of burn

Regression of new vessels

Secondary outcome:

Choroidal detachment

Retinal detachment

Tractional retinal detachment

Bruch's membrane rupture

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Arvind Eye Hospital, Madurai, Tamil Nadu 625 020, India

Starting date: December 2005
Ending date: July 2006
Last updated: August 4, 2007