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

University of Sao Paulo24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Diabetic Macular Edema

Interventions

Triamcinolone acetonideDRUG

4 mg

Triamcinolone acetonideDRUG

40 mg

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

Ribeirão Preto, São Paulo, Brazil

Outcomes

Primary Outcomes

central subfield macular thickness

Time frame: baseline and at 2, 4, 8±1 ,12±2 and 24±2 weeks postoperatively

Secondary Outcomes

Best Corrected Visual Acuity

Time frame: baseline and at 2, 4, 8±1, 12±2 and 24±2 weeks postoperatively

Intraocular pressure

Time frame: baseline and at 2, 4, 8±1 ,12±2 and 24±2 weeks postoperatively

Data from ClinicalTrials.gov

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