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Completed

NCT Number: NCT00355680

Green Laser Photocoagulation Study in Proliferative Diabetic Retinopathy

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

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Key information

Conditions

Diabetic Retinopathy Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Endocrine System Diseases Eye Diseases Retinal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Arvind Eye Hospital

Madurai, Tamil Nadu, 625 020, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Green Laser (Aurolas, Aurolab)

Device

Green laser developed by Aurolab

Other names: Aurolas

Green Laser (Iridex)

Device

Already available green laser

Other names: Iridex

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Aurolab

Other

Collaborators

  • Raja Ramanna Centre for Advanced Technology (RRCAT)

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Jul 24, 2006
Registry last updated
Feb 11, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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