Intravitreal Injection Versus Sub-Tenon's Infusion of Triamcinolone Acetonide for Refractory Diabetic Macular Edema During Cataract Surgery
- Registration Number
- NCT00801450
- Lead Sponsor
- University of Sao Paulo
- Brief Summary
Triamcinolone has already been used by different routes of administration to treat diabetic macular edema. In the present study, intravitreal injection (IVI) and posterior sub-Tenon's infusion (STI) of triamcinolone acetonide (TA) during phacoemulsification cataract surgery in eyes with refractory diffuse diabetic macular edema are tested.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
- Refractory diffuse DME unresponsive to focal laser photocoagulation
- Best corrected visual acuity between 20/800 and 20/40; Central subfield macular thickness greater than 300 µm
Exclusion Criteria
- Previous ocular surgery
- Glycosylated hemoglobin (Hb A1C) rate above 10%
- History of glaucoma or ocular hypertension
- Loss of vision as a result of other causes
- Systemic corticoid therapy
- Severe systemic disease
- Any condition affecting follow-up or documentation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SubTenon´s (STI) Triamcinolone acetonide - Intravitreal (IVI) Triamcinolone acetonide -
- Primary Outcome Measures
Name Time Method central subfield macular thickness baseline and at 2, 4, 8±1 ,12±2 and 24±2 weeks postoperatively
- Secondary Outcome Measures
Name Time Method Best Corrected Visual Acuity baseline and at 2, 4, 8±1, 12±2 and 24±2 weeks postoperatively Intraocular pressure baseline and at 2, 4, 8±1 ,12±2 and 24±2 weeks postoperatively
Trial Locations
- Locations (1)
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
🇧🇷Ribeirão Preto, São Paulo, Brazil