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

Proliferative Diabetic Retinopathy Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01044875
• Other study ID #: UMERC002
• Status: Recruiting
• Phase: N/A
• First received: January 7, 2010
• Last updated: January 7, 2010
• Start date: September 2009
• Est. completion date: October 2011

Study information

• Verified date: January 2010
• Source: University of Malaya
• Contact: Thirupathy Annamalai, MBBS
• Phone: +79492060
• Email: thirusukan[@]yahoo.com
• Is FDA regulated: No
• Health authority: Malaysia: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Proliferative Diabetic Retinopathy
• Retinal Diseases

Intervention

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.

Locations

Country	Name	City	State
Malaysia	University of Malaya Eye Research Centre	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity measurement by logarithm of the minimum angle of resolution (logMAR)		2 years	No
Secondary	Patient pain score during laser procedure		2 years	No