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

NCT ID: NCT01044875

Last Updated: 2010-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-10-31

Brief Summary

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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

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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.

Conditions

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Proliferative Diabetic Retinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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green laser 532 nm conventional

Current type of laser used for treatment of proliferative diabetic retinopathy

Group Type ACTIVE_COMPARATOR

Pan retinal photocoagulation laser treatment

Intervention Type PROCEDURE

Eyes with PDR are randomised to treatment with either the green laser 532 nm or 577 nm yellow laser.

Yellow 577 nm laser

new laser wavelength for treatment of PDR

Group Type ACTIVE_COMPARATOR

Pan retinal photocoagulation laser treatment

Intervention Type PROCEDURE

Eyes with PDR are randomised to treatment with either the green laser 532 nm or 577 nm yellow laser.

Interventions

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Pan retinal photocoagulation laser treatment

Eyes with PDR are randomised to treatment with either the green laser 532 nm or 577 nm yellow laser.

Intervention Type PROCEDURE

Other Intervention Names

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Quantel Supra 577nm laser

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Malaya

OTHER

Sponsor Role lead

Responsible Party

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University of Malaya

Principal Investigators

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Kenneth C Fong, FRCOphth

Role: PRINCIPAL_INVESTIGATOR

University of Malaya Eye Research Centre

Nurliza Khaliddin, FRCS

Role: PRINCIPAL_INVESTIGATOR

University of Malaya Eye Research Centre

Locations

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University of Malaya Eye Research Centre

Kuala Lumpur, Kuala Lumpur, Malaysia

Site Status RECRUITING

Countries

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Malaysia

Central Contacts

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Thirupathy Annamalai, MBBS

Role: CONTACT

+79492060

Facility Contacts

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Kenneth C Fong, FRCOphth

Role: primary

+60379492060

Other Identifiers

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UMERC002

Identifier Type: -

Identifier Source: org_study_id

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