Green Laser Photocoagulation Study in Proliferative Diabetic Retinopathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2006-07-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Diabetic Retinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Aurolab Green Laser

Group Type EXPERIMENTAL

Green Laser (Aurolas, Aurolab)

Intervention Type DEVICE

Green laser developed by Aurolab

2

Available Green Laser

Group Type ACTIVE_COMPARATOR

Green Laser (Iridex)

Intervention Type DEVICE

Already available green laser

Interventions

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Green Laser (Aurolas, Aurolab)

Green laser developed by Aurolab

Intervention Type DEVICE

Green Laser (Iridex)

Already available green laser

Intervention Type DEVICE

Other Intervention Names

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Aurolas Iridex

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No