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

• Sponsor: Federal University of São Paulo (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00552435
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 20.1
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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 Design

• Study Type: Interventional
• Anticipated 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: Mar 1, 2007
• Anticipated Primary Completion Date: Nov 1, 2008
• Anticipated Study Completion Date: Nov 1, 2008

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Macular thickness measured by optical coherence tomography (OCT) [12 months]

Secondary Outcome Measures

1. Safety profile [12 months]

2. Selectivity of laser therapy (autofluorescence and mfERG) [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vision Institute, Federal University of Sao Paulo	Sao Paulo	SP	Brazil

Sponsors and Collaborators

• Federal University of São Paulo

Investigators

• Principal Investigator: Jose A Cardillo, Federal University of Sao Paulo- Department of Ophthalmology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00552435
• Other Study ID Numbers: MP-001
• First Posted: Nov 2, 2007
• Last Update Posted: May 7, 2008
• Last Verified: May 1, 2008

• Additional relevant MeSH terms: Macular Edema; Edema

Study Results

No Results Posted as of May 7, 2008