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Sponsors and Collaborators: |
Aurolab Raja Ramanna Centre for Advanced Technology (RRCAT) |
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Information provided by: | Aurolab |
ClinicalTrials.gov Identifier: | NCT00355680 |
To Demonstrate that indigenous green laser produces similar treatment effect on the retina when compared with already available green laser.
Condition | Intervention | Phase |
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Diabetic Retinopathy |
Device: Green Laser (Aurolas, Aurolab) Device: Green Laser (Iridex) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Comparative Study of Indigenous Green Laser With Already Available Green Laser in Proliferative Diabetic Retinopathy |
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 |
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1: Experimental
Aurolab Green Laser
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Device: Green Laser (Aurolas, Aurolab)
Green laser developed by Aurolab
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2: Active Comparator
Available Green Laser
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Device: Green Laser (Iridex)
Already available green laser
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
India, Tamil Nadu | |
Arvind Eye Hospital | |
Madurai, Tamil Nadu, India, 625 020 |
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 |
Responsible Party: | Aurolab ( A. Heber ) |
Study ID Numbers: | 2PR1210511 |
Study First Received: | July 21, 2006 |
Last Updated: | July 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00355680 |
Health Authority: | India: Ministry of Health |
Retina Retinal Diseases Retinal Vessels Laser Coagulation |
Diabetic Retinopathy Eye Diseases Diabetes Mellitus Vascular Diseases Endocrine System Diseases |
Endocrinopathy Diabetes Complications Retinal Diseases Diabetic Angiopathies |
Cardiovascular Diseases |