Back to results

Green Laser Photocoagulation Study in Proliferative Diabetic Retinopathy

Primary Purpose

Diabetic Retinopathy

Status

Completed

Phase

Phase 3

Locations

India

Study Type

Interventional

Intervention

Green Laser (Aurolas, Aurolab)

Green Laser (Iridex)

About this trial

This is an interventional treatment trial for Diabetic Retinopathy focused on measuring Retina, Retinal Diseases, Retinal Vessels, Laser Coagulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arvind Eye Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Aurolab Green Laser

Available Green Laser

Outcomes

Primary Outcome Measures

Pigmentation of burn

Lateral spread of burn

Regression of new vessels

Secondary Outcome Measures

Choroidal detachment

Retinal detachment

Tractional retinal detachment

Bruch's membrane rupture

Full Information

NCT ID

NCT00355680

First Posted

July 21, 2006

Last Updated

February 10, 2009

Sponsor

Aurolab

Collaborators

Raja Ramanna Centre for Advanced Technology (RRCAT)

1. Study Identification

Unique Protocol Identification Number

NCT00355680

Brief Title

Green Laser Photocoagulation Study in Proliferative Diabetic Retinopathy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Completed

Study Start Date

December 2005 (undefined)

Primary Completion Date

July 2006 (Actual)

Study Completion Date

July 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Aurolab

Collaborators

Raja Ramanna Centre for Advanced Technology (RRCAT)

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Retinopathy

Keywords

Retina, Retinal Diseases, Retinal Vessels, Laser Coagulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Aurolab Green Laser

Arm Title

Arm Type

Active Comparator

Arm Description

Available Green Laser

Intervention Type

Device

Intervention Name(s)

Green Laser (Aurolas, Aurolab)

Other Intervention Name(s)

Aurolas

Intervention Description

Green laser developed by Aurolab

Intervention Type

Device

Intervention Name(s)

Green Laser (Iridex)

Other Intervention Name(s)

Iridex

Intervention Description

Already available green laser

Primary Outcome Measure Information:

Title

Pigmentation of burn

Time Frame