Micropulse 810 Nanomolar (nm), Diode Laser for Diffuse Diabetic Macular Edema

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00552435
Recruitment Status : Unknown
Verified May 2008 by Federal University of São Paulo.
Recruitment status was:  Recruiting
First Posted : November 2, 2007
Last Update Posted : May 7, 2008
Information provided by:
Federal University of São Paulo

Brief Summary:

Objective: To compare micropulse 810nm diode laser photocoagulation versus argon laser photocoagulation for treatment of diabetic macular edema. Micropulse laser technique will be determined by an initial clinical trial comparing single versus double density laser photocoagulation techniques for treatment of diabetic macular edema.The single density is based on the Early Treatment Diabetic Retinopathy Study (ETDRS) grid photocoagulation technique and the double density increases the number of spots.

Methods: Patients with diabetic macular edema will be assigned to receive either micropulse 810nm diode laser photocoagulation or argon laser photocoagulation therapy. First, in a smaller clinical trial, patients will be assigned to single or double density micropulse 810nm diode laser to determine best strategy for this therapy. Visual acuity, fundus photographs and fluorescein angiography, and optical coherence tomography measurements , autofluorescence and mfERG were obtained at baseline and at 1, 3 and 6 months and 12 months.

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Device: Laser photocoagulation Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Micropulse 810nm Diode Laser Photocoagulation for Treatment of Diffuse Diabetic Macular Edema
Study Start Date : March 2007
Estimated Primary Completion Date : November 2008
Estimated Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Micropulse 810nm diode laser
Device: Laser photocoagulation
Laser therapy is applied using a slit lamp and specific laser contact lens.
Active Comparator: 2
Argon laser photocoagulation
Device: Laser photocoagulation
Laser therapy is applied using a slit lamp and specific laser contact lens.

Primary Outcome Measures :
  1. Macular thickness measured by optical coherence tomography (OCT) [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Safety profile [ Time Frame: 12 months ]
  2. Selectivity of laser therapy (autofluorescence and mfERG) [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 and fluorescein angiography.
  • Best corrected visual acuity between 34 (20/200) and 68 letters (20/50).
  • Macular thickness greater than 300 mcm on OCT.

Exclusion Criteria:

  • Uncontrolled systemic disease
  • Start of medical therapy for diabetes or change in treatment from oral to insulin four months before initial visit.
  • HbA1c levels greater than 10%
  • Presence of retinal venous occlusion, cystoid macular edema,or other condition that would contribute to macular edema.
  • Presence of epiretinal membrane
  • Presence of vitreomacular traction in the study eye.
  • Neovascularization of disc or elsewhere in the study eye.
  • History or presence of choroidal neovascularization in the study eye.
  • Presence of rubeosis irides in the study eye.
  • Eye opacity that interfere with clinical documentation and photography.
  • Intra-ocular surgery 90 days before initial visit.
  • Scheduled surgery for study eye.
  • Patients with known allergies to fluorescein.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00552435

Contact: Daniel Lavinsky 55-11-7658-8669
Contact: Jose A Cardillo 55-16-8115-1000

Vision Institute, Federal University of Sao Paulo Recruiting
Sao Paulo, SP, Brazil
Contact: Daniel Lavinsky, MD    55-11-7658-8669      
Principal Investigator: Jose A Cardillo         
Principal Investigator: Michel E Farah         
Sub-Investigator: Paulo Hilarião         
Sub-Investigator: Leonardo Castro         
Sub-Investigator: Daniel Lavinsky         
Sponsors and Collaborators
Federal University of São Paulo
Principal Investigator: Jose A Cardillo Federal University of Sao Paulo- Department of Ophthalmology

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Federal University of Sao Paulo, Vision Institute Department of Ophthalmology Identifier: NCT00552435     History of Changes
Other Study ID Numbers: MP-001
First Posted: November 2, 2007    Key Record Dates
Last Update Posted: May 7, 2008
Last Verified: May 2008

Additional relevant MeSH terms:
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases