Green Laser Photocoagulation Study in Proliferative Diabetic Retinopathy

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00355680

Enrollment

Registered

2006-07-24

Start date

2005-12-31

Completion date

2006-07-31

Last updated

2009-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Retinopathy

Keywords

Retina, Retinal Diseases, Retinal Vessels, Laser Coagulation

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.

Interventions

DEVICEGreen Laser (Aurolas, Aurolab)

Green laser developed by Aurolab

DEVICEGreen Laser (Iridex)

Already available green laser

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Measure	Time frame
Choroidal detachment	2 months, 4 months, 6 months post laser
Bruch's membrane rupture	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

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026