Trial of Yellow 577 nm Laser Versus Green 532 nm Laser for Proliferative Diabetic Retinopathy
UMPDR
A Randomised Control Trial Comparing the Effectiveness of Yellow 577 nm Laser to Conventional Green 532 nm Laser for Proliferative Diabetic Retinopathy
1 other identifier
interventional
120
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 7, 2010
CompletedFirst Posted
Study publicly available on registry
January 8, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedJanuary 8, 2010
January 1, 2010
2 years
January 7, 2010
January 7, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visual acuity measurement by logarithm of the minimum angle of resolution (logMAR)
2 years
Secondary Outcomes (1)
Patient pain score during laser procedure
2 years
Study Arms (2)
green laser 532 nm conventional
ACTIVE COMPARATORCurrent type of laser used for treatment of proliferative diabetic retinopathy
Yellow 577 nm laser
ACTIVE COMPARATORnew laser wavelength for treatment of PDR
Interventions
Eyes with PDR are randomised to treatment with either the green laser 532 nm or 577 nm yellow laser.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Eyes with media opacity not allowing adequate laser photocoagulation
- Patients who have had previous laser photocoagulation
- Patients who have had previous vitreoretinal surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Malaya Eye Research Centre
Kuala Lumpur, Kuala Lumpur, 50603, Malaysia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kenneth C Fong, FRCOphth
University of Malaya Eye Research Centre
- PRINCIPAL INVESTIGATOR
Nurliza Khaliddin, FRCS
University of Malaya Eye Research Centre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 7, 2010
First Posted
January 8, 2010
Study Start
September 1, 2009
Primary Completion
September 1, 2011
Study Completion
October 1, 2011
Last Updated
January 8, 2010
Record last verified: 2010-01