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Micropulse 810 Nanomolar (nm), Diode Laser for Diffuse Diabetic Macular Edema
This study is currently recruiting participants.
Study NCT00552435   Information provided by Federal University of São Paulo
First Received: October 31, 2007   Last Updated: May 6, 2008   History of Changes

October 31, 2007
May 6, 2008
March 2007
November 2008   (final data collection date for primary outcome measure)
Macular thickness measured by optical coherence tomography (OCT) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Macular thickness measured by optical coherence tomography (OCT) [ Time Frame: 12 months ]
  • Best corrected visual acuity [ Time Frame: 12 months ]
Complete list of historical versions of study NCT00552435 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Safety profile [ Time Frame: 12 months ]
  • Selectivity of laser therapy (autofluorescence and mfERG) [ Time Frame: 12 months ]
 
Micropulse 810 Nanomolar (nm), Diode Laser for Diffuse Diabetic Macular Edema
Phase 2 Study of Micropulse 810nm Diode Laser Photocoagulation for Treatment of Diffuse Diabetic Macular Edema

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.

 
Phase II
Interventional
Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment
Diabetic Macular Edema
Device: Laser photocoagulation
  • Experimental: Micropulse 810nm diode laser
  • Active Comparator: Argon laser photocoagulation
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
50
November 2008
November 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Daniel Lavinsky 55-11-7658-8669 lavinsky@via-rs.net
Contact: Jose A Cardillo 55-16-8115-1000 hospitaldeolhos@uol.com.br
Brazil
 
NCT00552435
Federal University of Sao Paulo, Vision Institute Department of Ophthalmology
MP-001
Federal University of São Paulo
 
Principal Investigator: Jose A Cardillo Federal University of Sao Paulo- Department of Ophthalmology
Federal University of São Paulo
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP