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

Sponsor

University of Malaya (Other)

Overall Status

Unknown status

CT.gov ID

NCT01044875

Collaborator

(none)

120

Enrollment

Location

Arms

Duration (Months)

4.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Proliferative Diabetic Retinopathy	Procedure: Pan retinal photocoagulation laser treatment	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, 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

Study Start Date :

Sep 1, 2009

Anticipated Primary Completion Date :

Sep 1, 2011

Anticipated Study Completion Date :

Oct 1, 2011

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Visual acuity measurement by logarithm of the minimum angle of resolution (logMAR) [2 years]

Secondary Outcome Measures

Patient pain score during laser procedure [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of Malaya Eye Research Centre	Kuala Lumpur		Malaysia	50603

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