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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
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 ÎĽm 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | 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 | Experimental | triamcinolone as previously described |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intravitreous triamcinolone | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| diffuse macular oedema | 1, 3 and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| morphofunctional assessment of retina | 1,3 and 6 monts |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alberto L Gil, MD | Federal University of Health Science of Porto Alegre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de ClĂnicas de Porto Alegre | Porto Alegre | Rio Grande do Sul | 90035-003 | Brazil | ||
| HOspital de ClĂnicas de Porto alegre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22183994 | Derived | Gil AL, Azevedo MJ, Tomasetto GG, Muniz CH, Lavinsky J. Treatment of diffuse diabetic maculopathy with intravitreal triamcinolone and laser photocoagulation: randomized clinical trial with morphological and functional evaluation. Arq Bras Oftalmol. 2011 Sep-Oct;74(5):343-7. doi: 10.1590/s0004-27492011000500007. |
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| ID | Term |
|---|---|
| D008269 | Macular Edema |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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|
| laser therapy | Procedure | pan fotocoaglulation by laser therapy |
|
| Porto Alegre |
| Rio Grande do Sul |
| 9035/903 |
| Brazil |
| Hospital de ClĂnicas de Porto Alegre | Porto Alegre | Rio Grande do Sul | 90630040 | Brazil |
| D003920 |
| Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |