Micropulse 577 nm Laser Photocoagulation Versus Conventional 532 nm Laser Photocoagulation for Diabetic Macular Oedema

NCT01045239 | Unknown Phase 2 DMC

• 1 other identifier: UMERC001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether the new micropulse 577 nm yellow laser is a better treatment option compared to the conventional 532 nm green laser for diabetic macular edema.

Conditions

Diabetic Macular Edema

Keywords

Diabetic macular edema; Diabetic macular oedema; micropulse laser; laser treatment; macular thickness

Outcome Measures

Primary Outcomes (1)

• Best corrected visual acuity by logarithm of the minimum angle of resolution (LogMAR)

  1 year

Secondary Outcomes (2)

• Macular thickness measured by optical coherence tomography (OCT)

  12 months

• Photocoagulation scars on fundus photograph

  12 months

Study Arms (2)

Micropulse 577 nm yellow diode laser

EXPERIMENTAL

Device: Micropulse 577 nm yellow diode laser

532 nm green diode laser

ACTIVE COMPARATOR

Device: 532 nm green diode laser

Interventions

Micropulse 577 nm yellow diode laser DEVICE

Laser administered at beginning of study and may be repeated at 16 weeks if needed

Also known as: Quantel Supra 577nm laser

Micropulse 577 nm yellow diode laser

532 nm green diode laser DEVICE

Laser administered at beginning of study and may be repeated at 16 weeks if needed

532 nm green diode laser

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diabetes mellitus (type 1 or 2)
• Diabetic macular edema in study eye associated to diabetic retinopathy
• Diffuse macular edema defined as macular thickening determined by biomicroscopy, OCT and/or fluorescein angiography.
• Best corrected visual acuity between 34 (20/200) and 68 letters (20/50).
• Macular thickness greater than 300 mcm on OCT.

You may not qualify if:

• Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
• A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
• Blood pressure \> 180/110 (systolic above 180 OR diastolic above 110).
• Subject is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the next 6 months.
• Macular edema is considered to be due to a cause other than diabetic macular edema.
• Presence of vitreomacular traction.
• Concurrent proliferative diabetic retinopathy.
• An ocular condition is present such that, in the opinion of the investigator, visual acuity loss would not improve from resolution of macular edema (e.g., foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, significant macular ischemia, nonretinal condition).
• An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (e.g., vein occlusion, uveitis epiretinal membrane, or other ocular inflammatory disease, neovascular glaucoma, etc.).
• Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more (i.e., cataract would be reducing acuity to 20/40 or worse if eye was otherwise normal).
• History of treatment for DME at any time in the past 4 months (such as focal/grid macular photocoagulation, intravitreal or peribulbar corticosteroids, anti-VEGF drugs, or any other treatment).
• History of panretinal (scatter) photocoagulation (PRP) prior to enrollment or anticipated to be performed within next 6 months.
• History of major ocular surgery (including vitrectomy, cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 12 months or anticipated within the next 6 months.
• History of YAG capsulotomy performed within 2 months prior to enrollment.

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

University Malaya Eye Research Centre

Kuala Lumpur, 59100, Malaysia

RECRUITING

MeSH Terms

Interventions

Lasers

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Kenneth C Fong, FRCOphth

  University of Malaya Eye Research Centre

  PRINCIPAL INVESTIGATOR

• Tajunisah Iqbal, FRCS

  University of Malaya Eye Research Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linda Ong, MBBS

CONTACT

+603-79494422; lindaong@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 7, 2010
• First Posted: January 8, 2010
• Study Start: October 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: January 1, 2012
• Last Updated: January 8, 2010

Record last verified: 2010-01

Locations

MY (1)