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

University of Sao Paulo1 site in 1 country24 target enrollmentSeptember 2007

ConditionsDiabetic Macular Edema

InterventionsTriamcinolone acetonide

DrugsTriamcinolone acetonide

Overview

Phase: Phase 1
Intervention: Triamcinolone acetonide
Conditions: Diabetic Macular Edema
Sponsor: University of Sao Paulo
Enrollment: 24
Locations: 1
Primary Endpoint: central subfield macular thickness
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2007

End Date

February 2009

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Sao Paulo

Eligibility 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

Arms & Interventions

Intravitreal (IVI)

Intervention: Triamcinolone acetonide

SubTenon´s (STI)

Intervention: Triamcinolone acetonide

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(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)