NCT00668239

Diffuse Diabetic Maculopathy With Intravitreal Triamcinolone or Laser

Treatment of Diffuse Diabetic Maculopathy With Intravitreal Triamcinolone and Laser Photocoagulation: Randomized Clinical Trial With Morphological and Functional Evaluation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Hospital de Clinicas de Porto Alegre · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

This study compares the use of intravitreous triamcinolone and laser therapy to treat maculopahty in patients with type 2 diabetes mellitus in a short-tem period of 6 months

Detailed description

The purpose of this double blind randomized clinical trial was to compare the treatment of diffuse diabetic macular oedema with intravitreal triamcinolone and laser in patients with type 2 diabetes mellitus (DM), using a morphofunctional assessment. Patients with clinically significant diffuse macular oedema, previously untreated and with a macular thickness \>250 μm at optical coherence tomography (OCT) were randomized for treatment with Laser or intravitreal injection of Triamcinolone acetate. Optical coherence tomography (OCT), biomicroscopy, fundoscopy, fluorescein angiography, tonometry, scotometry, visual acuity and contrast acuities were performed at 0, 1, 3 and 6 months.

Conditions

• Macular Edema

Interventions

Type	Name	Description
DRUG	intravitreous triamcinolone	Intravenous injection of 0.1 ml (4 mg) of triamcinolone acetate was performed through the pars plana in a surgical environment. The medication used was manipulated by the Ophthalmos chemist. This type of formulation is different from the similar American one (Kenalog ®) since it does not use a conservation agent
PROCEDURE	laser therapy	pan fotocoaglulation by laser therapy

Timeline

• Start date: 2004-09-01
• Primary completion: 2006-04-01
• Completion: 2006-06-01
• First posted: 2008-04-29
• Last updated: 2008-04-29

Locations

3 sites across 1 country: Brazil