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

Not Applicable

• Conditions: Proliferative Diabetic Retinopathy
• Interventions: Procedure: Pan retinal photocoagulation laser treatment

• Registration Number: NCT01044875
• Lead Sponsor: University of Malaya

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.

Study Timeline

• Study Start: 2009-09
• Status Verified: 2010-01
• Study First Submitted: 2010-01-07
• Study First Submitted QC: 2010-01-07
• Last Update Submitted: 2010-01-07
• Study First Posted: 2010-01-08
• Last Update Posted: 2010-01-08
• Primary Completion: 2011-09
• Study Completion: 2011-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
green laser 532 nm conventional	Pan retinal photocoagulation laser treatment	Current type of laser used for treatment of proliferative diabetic retinopathy
Yellow 577 nm laser	Pan retinal photocoagulation laser treatment	new laser wavelength for treatment of PDR

Primary Outcome Measures

Name	Time	Method
Visual acuity measurement by logarithm of the minimum angle of resolution (logMAR)	2 years

Secondary Outcome Measures

Name	Time	Method
Patient pain score during laser procedure	2 years

Trial Locations

Locations (1)

University of Malaya Eye Research Centre; 🇲🇾 Kuala Lumpur, Malaysia