Treatment of Diffuse Diabetic Maculopathy With Intravitreal Triamcinolone and Laser Photocoagulation: Randomized Clinical Trial With Morphological and Functional Evaluation
Overview
- Phase
- Not Applicable
- Intervention
- laser therapy
- Conditions
- Macular Edema
- Sponsor
- Hospital de Clinicas de Porto Alegre
- Enrollment
- 14
- Locations
- 2
- Primary Endpoint
- diffuse macular oedema
- Status
- Completed
- Last Updated
- 18 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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,
Exclusion Criteria
- •patients with type 2 DM and previous treatment of diffuse macular oedema secondary to diabetic retinopathy
Arms & Interventions
1
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
Intervention: laser therapy
2
triamcinolone as previously described
Intervention: intravitreous triamcinolone
Outcomes
Primary Outcomes
diffuse macular oedema
Time Frame: 1, 3 and 6 months
Secondary Outcomes
- morphofunctional assessment of retina(1,3 and 6 monts)