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Green Laser Photocoagulation Study in Proliferative Diabetic Retinopathy

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ClinicalTrials.gov Identifier: NCT00355680
Recruitment Status : Completed
First Posted : July 24, 2006
Last Update Posted : February 11, 2009
Sponsor:
Collaborator:
Raja Ramanna Centre for Advanced Technology (RRCAT)
Information provided by:
Aurolab

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

Condition or disease Intervention/treatment Phase
Diabetic Retinopathy Device: Green Laser (Aurolas, Aurolab) Device: Green Laser (Iridex) Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Study of Indigenous Green Laser With Already Available Green Laser in Proliferative Diabetic Retinopathy
Study Start Date : December 2005
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
Aurolab Green Laser
Device: Green Laser (Aurolas, Aurolab)
Green laser developed by Aurolab
Other Name: Aurolas

Active Comparator: 2
Available Green Laser
Device: Green Laser (Iridex)
Already available green laser
Other Name: Iridex




Primary Outcome Measures :
  1. Pigmentation of burn [ Time Frame: 2 months, 4 months, 6 months post laser ]
  2. Lateral spread of burn [ Time Frame: 2 months, 4 months, 6 months post laser ]
  3. Regression of new vessels [ Time Frame: 2 months, 4 months, 6 months post laser ]

Secondary Outcome Measures :
  1. Choroidal detachment [ Time Frame: 2 months, 4 months, 6 months post laser ]
  2. Retinal detachment [ Time Frame: 2 months, 4 months, 6 months post laser ]
  3. Tractional retinal detachment [ Time Frame: 2 months, 4 months, 6 months post laser ]
  4. Bruch's membrane rupture [ Time Frame: 2 months, 4 months, 6 months post laser ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00355680


Locations
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India
Arvind Eye Hospital
Madurai, Tamil Nadu, India, 625 020
Sponsors and Collaborators
Aurolab
Raja Ramanna Centre for Advanced Technology (RRCAT)
Investigators
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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

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Responsible Party: A. Heber, Aurolab
ClinicalTrials.gov Identifier: NCT00355680     History of Changes
Other Study ID Numbers: 2PR1210511
First Posted: July 24, 2006    Key Record Dates
Last Update Posted: February 11, 2009
Last Verified: February 2009
Keywords provided by Aurolab:
Retina
Retinal Diseases
Retinal Vessels
Laser Coagulation
Additional relevant MeSH terms:
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Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases