Intravitreal Injection Versus Sub-Tenon's Infusion of Triamcinolone Acetonide for Refractory Diabetic Macular Edema During Cataract Surgery

• Status: Unknown status
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sao Paulo
• Collaborator: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Treatments: Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

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