Micropulse 810 Nanomolar (nm), Diode Laser for Diffuse Diabetic Macular Edema
NCT ID: NCT00552435
Last Updated: 2008-05-07
Study Results
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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UNKNOWN
PHASE2
50 participants
INTERVENTIONAL
2007-03-31
2008-11-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
Micropulse 810nm diode laser
Laser photocoagulation
Laser therapy is applied using a slit lamp and specific laser contact lens.
2
Argon laser photocoagulation
Laser photocoagulation
Laser therapy is applied using a slit lamp and specific laser contact lens.
Interventions
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Laser photocoagulation
Laser therapy is applied using a slit lamp and specific laser contact lens.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Federal University of São Paulo
OTHER
Responsible Party
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Vision Institute Department of Ophthalmology
Principal Investigators
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Jose A Cardillo
Role: PRINCIPAL_INVESTIGATOR
Federal University of Sao Paulo- Department of Ophthalmology
Locations
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Vision Institute, Federal University of Sao Paulo
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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Daniel Lavinsky, MD
Role: primary
References
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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. doi: 10.1167/iovs.10-6828.
Other Identifiers
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MP-001
Identifier Type: -
Identifier Source: org_study_id