Micropulse 810 Nanomolar (nm), Diode Laser for Diffuse Diabetic Macular Edema - Full Text View

Sponsor:	Federal University of São Paulo
Information provided by:	Federal University of São Paulo
ClinicalTrials.gov Identifier:	NCT00552435

Purpose

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	Intervention	Phase
Diabetic Macular Edema	Device: Laser photocoagulation	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Phase 2 Study of Micropulse 810nm Diode Laser Photocoagulation for Treatment of Diffuse Diabetic Macular Edema

Resource links provided by NLM:

Genetics Home Reference related topics: age-related macular degeneration X-linked juvenile retinoschisis

MedlinePlus related topics: Edema

U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:

Macular thickness measured by optical coherence tomography (OCT) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety profile [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Selectivity of laser therapy (autofluorescence and mfERG) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	50
Study Start Date:	March 2007
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00552435

Contacts

Contact: Daniel Lavinsky	55-11-7658-8669	lavinsky@via-rs.net
Contact: Jose A Cardillo	55-16-8115-1000	hospitaldeolhos@uol.com.br

Locations

Brazil
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

Investigators

Principal Investigator:

Jose A Cardillo

Federal University of Sao Paulo- Department of Ophthalmology

More Information

No publications provided by Federal University of São Paulo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lavinsky D, Cardillo JA, Melo LA Jr, Dare A, Farah ME, Belfort R Jr. Randomized clinical trial evaluating mETDRS versus normal or high-density micropulse photocoagulation for diabetic macular edema. Invest Ophthalmol Vis Sci. 2011 Jun 17;52(7):4314-23. Print 2011 Jun.

Responsible Party:	Federal University of Sao Paulo, Vision Institute Department of Ophthalmology
ClinicalTrials.gov Identifier:	NCT00552435 History of Changes
Other Study ID Numbers:	MP-001
Study First Received:	October 31, 2007
Last Updated:	May 6, 2008
Health Authority:	Brazil: National Committee of Ethics in Research; Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:

Edema
Macular Edema
Signs and Symptoms
Macular Degeneration

Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on February 13, 2012