Green Laser Photocoagulation Study in Proliferative Diabetic Retinopathy

February 10, 2009 updated by: Aurolab

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Aurolab Green Laser
Device: Green Laser (Aurolas, Aurolab)
Green laser developed by Aurolab
Other Names:
  • Aurolas
Active Comparator: 2
Available Green Laser
Device: Green Laser (Iridex)
Already available green laser
Other Names:
  • Iridex

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aurolab

Collaborators

Raja Ramanna Centre for Advanced Technology (RRCAT)

Investigators

  • Principal Investigator: Chandra Mohan, MS, Arvind Eye Hospital, Madurai
  • Principal Investigator: Dhananjay Shukla, MS, Aravind Eye Hospital
  • Principal Investigator: Naresh Babu, MS, FNB, Aravind Eye Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

July 21, 2006

First Submitted That Met QC Criteria

July 21, 2006

First Posted (Estimate)

July 24, 2006

Study Record Updates

Last Update Posted (Estimate)

February 11, 2009

Last Update Submitted That Met QC Criteria

February 10, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2PR1210511

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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