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CompletedNCT00355680Updated Feb 11, 2009

Green Laser Photocoagulation Study in Proliferative Diabetic Retinopathy

A Phase 3 interventional study of Green Laser (Aurolas, Aurolab) and Green Laser (Iridex) in Diabetic Retinopathy, sponsored by Aurolab. Completed at 1 site in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-02-11.

Sponsored by Aurolab · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Diabetic Retinopathy

Keywords

  • Retina
  • Retinal Diseases
  • Retinal Vessels
  • Laser Coagulation
03

In context

Retinal Diseases

815 studies on the registry are indexed under Retinal Diseases; 105 are open to participants now.

This study's enrollment of 24 is below the median of 60 across 500 interventional studies indexed under Retinal Diseases.

Browse Retinal Diseases studies →

Lead sponsor

Aurolab is the lead sponsor of 15 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients more than 18 years of age
  • Eyes with proliferative diabetic retinopathy requiring laser photocoagulation

Exclusion criteria

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    1

    Aurolab Green Laser

    Device: Green Laser (Aurolas, Aurolab)

  • Active comparator
    2

    Available Green Laser

    Device: Green Laser (Iridex)

Interventions

  • DeviceGreen Laser (Aurolas, Aurolab)

    Green laser developed by Aurolab

    Also known as: Aurolas

  • DeviceGreen Laser (Iridex)

    Already available green laser

    Also known as: Iridex

06

What researchers measure

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

07

Study locations

1 site
  • Arvind Eye Hospital
    Madurai, Tamil Nadu 625 020, India
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00355680
Lead sponsor
Aurolab
Collaborators
Raja Ramanna Centre for Advanced Technology (RRCAT)
First posted
Jul 24, 2006
Start date
Dec 2005
Primary completion
Jul 2006
Completion
Jul 2006
Last update
Feb 11, 2009

Study contacts

Chandra Mohan, MS
principal investigator · Arvind Eye Hospital, Madurai
Dhananjay Shukla, MS
principal investigator · Aravind Eye Hospital
Naresh Babu, MS, FNB
principal investigator · Aravind Eye Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.

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