Trial of Yellow 577 nm Laser Versus Green 532 nm Laser for Proliferative Diabetic Retinopathy (UMPDR)
Primary Purpose
Proliferative Diabetic Retinopathy
Status
Unknown status
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Pan retinal photocoagulation laser treatment
Sponsored by
About this trial
This is an interventional treatment trial for Proliferative Diabetic Retinopathy focused on measuring Diabetic retinopathy, Laser treatment, Complications, Laser wavelength
Eligibility 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
Sites / Locations
- University of Malaya Eye Research CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
green laser 532 nm conventional
Yellow 577 nm laser
Arm Description
Current type of laser used for treatment of proliferative diabetic retinopathy
new laser wavelength for treatment of PDR
Outcomes
Primary Outcome Measures
Visual acuity measurement by logarithm of the minimum angle of resolution (logMAR)
Secondary Outcome Measures
Patient pain score during laser procedure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01044875
Brief Title
Trial of Yellow 577 nm Laser Versus Green 532 nm Laser for Proliferative Diabetic Retinopathy
Acronym
UMPDR
Official Title
A Randomised Control Trial Comparing the Effectiveness of Yellow 577 nm Laser to Conventional Green 532 nm Laser for Proliferative Diabetic Retinopathy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
September 2011 (Anticipated)
Study Completion Date
October 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Malaya
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proliferative Diabetic Retinopathy
Keywords
Diabetic retinopathy, Laser treatment, Complications, Laser wavelength
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
green laser 532 nm conventional
Arm Type
Active Comparator
Arm Description
Current type of laser used for treatment of proliferative diabetic retinopathy
Arm Title
Yellow 577 nm laser
Arm Type
Active Comparator
Arm Description
new laser wavelength for treatment of PDR
Intervention Type
Procedure
Intervention Name(s)
Pan retinal photocoagulation laser treatment
Other Intervention Name(s)
Quantel Supra 577nm laser
Intervention Description
Eyes with PDR are randomised to treatment with either the green laser 532 nm or 577 nm yellow laser.
Primary Outcome Measure Information:
Title
Visual acuity measurement by logarithm of the minimum angle of resolution (logMAR)
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Patient pain score during laser procedure
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thirupathy Annamalai, MBBS
Phone
+79492060
Email
thirusukan@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth C Fong, FRCOphth
Organizational Affiliation
University of Malaya Eye Research Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nurliza Khaliddin, FRCS
Organizational Affiliation
University of Malaya Eye Research Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Malaya Eye Research Centre
City
Kuala Lumpur
ZIP/Postal Code
50603
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenneth C Fong, FRCOphth
Phone
+60379492060
Email
fongcsk@um.edu.my
12. IPD Sharing Statement
Learn more about this trial
Trial of Yellow 577 nm Laser Versus Green 532 nm Laser for Proliferative Diabetic Retinopathy
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