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

University of Sao Paulo

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Diabetic Macular Edema

Treatments: Drug: Triamcinolone acetonide

Study type: Interventional

Funder types: Other

Identifiers

NCT00801450

2995/2007

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups

Intravitreal (IVI)

Experimental group

Treatment:

Drug: Triamcinolone acetonide

Drug: Triamcinolone acetonide

SubTenon´s (STI)

Experimental group

Treatment:

Drug: Triamcinolone acetonide

Drug: Triamcinolone acetonide