NCT01044875

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 8, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

January 8, 2010

Status Verified

January 1, 2010

Enrollment Period

2 years

First QC Date

January 7, 2010

Last Update Submit

January 7, 2010

Conditions

Keywords

Diabetic retinopathyLaser treatmentComplicationsLaser wavelength

Outcome Measures

Primary Outcomes (1)

  • Visual acuity measurement by logarithm of the minimum angle of resolution (logMAR)

    2 years

Secondary Outcomes (1)

  • Patient pain score during laser procedure

    2 years

Study Arms (2)

green laser 532 nm conventional

ACTIVE COMPARATOR

Current type of laser used for treatment of proliferative diabetic retinopathy

Procedure: Pan retinal photocoagulation laser treatment

Yellow 577 nm laser

ACTIVE COMPARATOR

new laser wavelength for treatment of PDR

Procedure: Pan retinal photocoagulation laser treatment

Interventions

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

Also known as: Quantel Supra 577nm laser
Yellow 577 nm lasergreen laser 532 nm conventional

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Eyes with media opacity not allowing adequate laser photocoagulation
  • Patients who have had previous laser photocoagulation
  • Patients who have had previous vitreoretinal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Malaya Eye Research Centre

Kuala Lumpur, Kuala Lumpur, 50603, Malaysia

RECRUITING

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

Lasers

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Optical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • Kenneth C Fong, FRCOphth

    University of Malaya Eye Research Centre

    PRINCIPAL INVESTIGATOR
  • Nurliza Khaliddin, FRCS

    University of Malaya Eye Research Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thirupathy Annamalai, MBBS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 7, 2010

First Posted

January 8, 2010

Study Start

September 1, 2009

Primary Completion

September 1, 2011

Study Completion

October 1, 2011

Last Updated

January 8, 2010

Record last verified: 2010-01

Locations