Status:
UNKNOWN
Intravitreal Injection Versus Sub-Tenon's Infusion of Triamcinolone Acetonide for Refractory Diabetic Macular Edema During Cataract Surgery
Lead Sponsor:
University of Sao Paulo
Collaborating Sponsors:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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) o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00801450
Start Date
September 1 2007
End Date
February 1 2009
Last Update
October 12 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Ribeirão Preto, São Paulo, Brazil, 14049-900