Diffuse Diabetic Maculopathy With Intravitreal Triamcinolone or Laser
- Conditions
- Macular Edema
- Interventions
- Procedure: laser therapy
- Registration Number
- NCT00668239
- Lead Sponsor
- Hospital de Clinicas de Porto Alegre
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
- patients with type 2 DM, diffuse macular oedema secondary to diabetic retinopathy, seen at the Centre of Reference for Diabetic Retinopathy at Hospital de Clinicas de Porto Alegre (HCPA) and at the Ophthalmology Outpatient Clinic at HCPA,
- patients with type 2 DM and previous treatment of diffuse macular oedema secondary to diabetic retinopathy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 laser therapy Laser treatment: laser was applied to the macular region according to the modified grid technique in inverted C, preserving 500 μ of the foveolus and avascular zone, with 100μ diameter shots, energy varying from 0.2 to 0.5 joules, with a time of exposure between 0.2 and 0.4 seconds. One hundred and fifty to 200 shots were applied according to the size of the retinal area². ND YAG laser (Crystal Focus (EMERED®) was used 2 intravitreous triamcinolone triamcinolone as previously described
- Primary Outcome Measures
Name Time Method diffuse macular oedema 1, 3 and 6 months
- Secondary Outcome Measures
Name Time Method morphofunctional assessment of retina 1,3 and 6 monts
Trial Locations
- Locations (2)
Hospital de Clínicas de Porto Alegre
🇧🇷Porto Alegre, RS, Brazil
HOspital de Clínicas de Porto alegre
🇧🇷Porto alegre, RS, Brazil