Green Laser Photocoagulation Study in Proliferative Diabetic Retinopathy - Full Text View

Sponsor:	Aurolab
Collaborator:	Raja Ramanna Centre for Advanced Technology (RRCAT)
Information provided by:	Aurolab
ClinicalTrials.gov Identifier:	NCT00355680

Purpose

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

Condition	Intervention	Phase
Diabetic Retinopathy	Device: Green Laser (Aurolas, Aurolab) Device: Green Laser (Iridex)	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Comparative Study of Indigenous Green Laser With Already Available Green Laser in Proliferative Diabetic Retinopathy

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Burns Diabetic Eye Problems Retinal Disorders

U.S. FDA Resources

Further study details as provided by Aurolab:

Primary Outcome Measures:

Pigmentation of burn [ Time Frame: 2 months, 4 months, 6 months post laser ] [ Designated as safety issue: No ]
Lateral spread of burn [ Time Frame: 2 months, 4 months, 6 months post laser ] [ Designated as safety issue: No ]
Regression of new vessels [ Time Frame: 2 months, 4 months, 6 months post laser ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Choroidal detachment [ Time Frame: 2 months, 4 months, 6 months post laser ] [ Designated as safety issue: Yes ]
Retinal detachment [ Time Frame: 2 months, 4 months, 6 months post laser ] [ Designated as safety issue: Yes ]
Tractional retinal detachment [ Time Frame: 2 months, 4 months, 6 months post laser ] [ Designated as safety issue: Yes ]
Bruch's membrane rupture [ Time Frame: 2 months, 4 months, 6 months post laser ] [ Designated as safety issue: Yes ]

Enrollment:	24
Study Start Date:	December 2005
Study Completion Date:	July 2006
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00355680

Locations

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

Sponsors and Collaborators

Aurolab

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

More Information

No publications provided

Responsible Party:	A. Heber, Aurolab
ClinicalTrials.gov Identifier:	NCT00355680 History of Changes
Other Study ID Numbers:	2PR1210511
Study First Received:	July 21, 2006
Last Updated:	February 10, 2009
Health Authority:	India: Ministry of Health

Keywords provided by Aurolab:

Retina
Retinal Diseases
Retinal Vessels
Laser Coagulation

Additional relevant MeSH terms:

Diabetic Retinopathy
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases

Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on February 09, 2012