Diffuse Diabetic Maculopathy With Intravitreal Triamcinolone or Laser

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Macular Edema

Intervention / Treatment
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* Drug: intravitreous triamcinolone
* Procedure: laser therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>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 | Procedure: laser therapy<br>* pan fotocoaglulation by laser therapy<br>|
| Experimental: 2<br>triamcinolone as previously described | Drug: intravitreous triamcinolone<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diffuse macular oedema |  | 1, 3 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morphofunctional assessment of retina |  | 1,3 and 6 monts | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diffuse macular oedema, type 2 diabetes mellitus, laser therapy