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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University of Malaya.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Malaya
ClinicalTrials.gov Identifier:
NCT01044875
First received: January 7, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Proliferative Diabetic Retinopathy
 Procedure: Pan retinal photocoagulation laser treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised Control Trial Comparing the Effectiveness of Yellow 577 nm Laser to Conventional Green 532 nm Laser for Proliferative Diabetic Retinopathy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Malaya:

Primary Outcome Measures:
  • Visual acuity measurement by logarithm of the minimum angle of resolution (logMAR) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient pain score during laser procedure [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: September 2009
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Quantel Supra 577nm laser

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01044875

Contacts
Contact: Thirupathy Annamalai, MBBS +79492060 thirusukan@yahoo.com

Locations
Malaysia
University of Malaya Eye Research Centre Recruiting
Kuala Lumpur, Malaysia, 50603
Contact: Kenneth C Fong, FRCOphth     +60379492060     fongcsk@um.edu.my    
Sponsors and Collaborators
University of Malaya
Investigators
Principal Investigator: Kenneth C Fong, FRCOphth University of Malaya Eye Research Centre
Principal Investigator: Nurliza Khaliddin, FRCS University of Malaya Eye Research Centre
  More Information

No publications provided

Responsible Party: Assoc Prof Kenneth C S Fong, University of Malaya
ClinicalTrials.gov Identifier: NCT01044875     History of Changes
Other Study ID Numbers: UMERC002
Study First Received: January 7, 2010
Last Updated: January 7, 2010
Health Authority: Malaysia: Ministry of Health

Keywords provided by University of Malaya:
Diabetic retinopathy
Laser treatment
Complications
Laser wavelength

Additional relevant MeSH terms:
Diabetic Retinopathy
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
 Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013