Trial of Yellow 577 nm Laser Versus Green 532 nm Laser for Proliferative Diabetic Retinopathy (UMPDR)

January 7, 2010 updated by: University of Malaya

A Randomised Control Trial Comparing the Effectiveness of Yellow 577 nm Laser to Conventional Green 532 nm Laser for Proliferative Diabetic Retinopathy

The purpose of this study is to measure effectiveness of yellow 577 nm laser compared to conventional green laser 532 nm for diabetic retinopathy in terms of number of treatment sessions required and visual acuity outcome.

The study also compares pain score of patients receiving laser treatment and side effects of laser treatment.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Diabetes mellitus (DM) is a major medical problem throughout the world. The most common and potentially most blinding of these complications is proliferative diabetic retinopathy (PDR).

Panretinal photocoagulation is established as the gold standard of treatment, supported by the data of the Diabetic Retinopathy Study (DRS).This study found that laser treatment reduced the rate of severe visual loss by 50%. Currently the green 532nm laser is the most common wavelength used. However, this conventional green laser has some complications such as pain, vitreous haemorrhage, choroidal effusion and visual field loss.

Due to the complication of conventional lasers, the yellow laser (577 nm)with peak absorption of oxyhemoglobin and good absorption of melanin is postulated to be more effective at producing retinal laser burns with a lower power and less pain compared to the green laser.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Malaysia
      • Kuala Lumpur, Malaysia, 50603
        • Recruiting
        • University of Malaya Eye Research Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient more than 18 year of age
  • Eyes with proliferative diabetic retinopathy requiring laser PRP
  • Newly diagnosed patient
  • Patients with no other intervention/surgeries done before the study

Exclusion Criteria:

  • Eyes with media opacity not allowing adequate laser photocoagulation
  • Patients who have had previous laser photocoagulation
  • Patients who have had previous vitreoretinal surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: green laser 532 nm conventional
Current type of laser used for treatment of proliferative diabetic retinopathy
Procedure: Pan retinal photocoagulation laser treatment
Eyes with PDR are randomised to treatment with either the green laser 532 nm or 577 nm yellow laser.
Other Names:
  • Quantel Supra 577nm laser
ACTIVE_COMPARATOR: Yellow 577 nm laser
new laser wavelength for treatment of PDR
Procedure: Pan retinal photocoagulation laser treatment
Eyes with PDR are randomised to treatment with either the green laser 532 nm or 577 nm yellow laser.
Other Names:
  • Quantel Supra 577nm laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual acuity measurement by logarithm of the minimum angle of resolution (logMAR)
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient pain score during laser procedure
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaya

Investigators

  • Principal Investigator: Nurliza Khaliddin, FRCS, University of Malaya Eye Research Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (ANTICIPATED)

September 1, 2011

Study Completion (ANTICIPATED)

October 1, 2011

Study Registration Dates

First Submitted

January 7, 2010

First Submitted That Met QC Criteria

January 7, 2010

First Posted (ESTIMATE)

January 8, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

January 8, 2010

Last Update Submitted That Met QC Criteria

January 7, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMERC002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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