NCT00355680

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2005

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

July 21, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 24, 2006

Completed
Last Updated

February 11, 2009

Status Verified

February 1, 2009

Enrollment Period

7 months

First QC Date

July 21, 2006

Last Update Submit

February 10, 2009

Conditions

Diabetic Retinopathy

Keywords

RetinaRetinal DiseasesRetinal VesselsLaser Coagulation

Outcome Measures

Primary Outcomes (3)

  • Pigmentation of burn

    2 months, 4 months, 6 months post laser

  • Lateral spread of burn

    2 months, 4 months, 6 months post laser

  • Regression of new vessels

    2 months, 4 months, 6 months post laser

Secondary Outcomes (4)

  • Choroidal detachment

    2 months, 4 months, 6 months post laser

  • Retinal detachment

    2 months, 4 months, 6 months post laser

  • Tractional retinal detachment

    2 months, 4 months, 6 months post laser

  • Bruch's membrane rupture

    2 months, 4 months, 6 months post laser

Study Arms (2)

1

EXPERIMENTAL

Aurolab Green Laser

Device: Green Laser (Aurolas, Aurolab)

2

ACTIVE COMPARATOR

Available Green Laser

Device: Green Laser (Iridex)

Interventions

Green Laser (Aurolas, Aurolab)DEVICE

Green laser developed by Aurolab

Also known as: Aurolas
1
Green Laser (Iridex)DEVICE

Already available green laser

Also known as: Iridex
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arvind Eye Hospital

Madurai, Tamil Nadu, 625 020, India

Location

MeSH Terms

Conditions

Diabetic RetinopathyRetinal Diseases

Condition Hierarchy (Ancestors)

Eye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Chandra Mohan, MS

    Arvind Eye Hospital, Madurai

    PRINCIPAL INVESTIGATOR

  • Dhananjay Shukla, MS

    Aravind Eye Hospital

    PRINCIPAL INVESTIGATOR

  • Naresh Babu, MS, FNB

    Aravind Eye Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 21, 2006

First Posted

July 24, 2006

Study Start

December 1, 2005

Primary Completion

July 1, 2006

Study Completion

July 1, 2006

Last Updated

February 11, 2009

Record last verified: 2009-02

Locations

IN(1)