N/A N=11 Randomized Treatment

Triamcinolone vs. Laser for Diabetic Macular Edema

DIABETIC MACULAR EDEMA

Bottom Line

View on ClinicalTrials.gov: NCT00229931 ↗

Enrolled (actual)

Serious AEs

9.1%

Results posted

Jul 2017

Primary outcome: Primary: Main Outcome Measures Will be Quantitative Changes in OCT Central Thickness, Visual Acuity, and Number of Snellen Acuity Lines Gained/Lost.

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Triamcinolone acetonide (Drug); laser (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Oklahoma
Primary completion: May 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Main Outcome Measures Will be Quantitative Changes in OCT Central Thickness, Visual Acuity, and Number of Snellen Acuity Lines Gained/Lost.	—	—
SECONDARY Rate of Elevated Intraocular Pressures, Retinal Detachment, Infection, and Vitreous Hemorrhage.	—	—

Summary

The purpose of this study is to determine if intravitreal triamcinolone acetonide (IVTA) injection at the time of cataract surgery will improve visual acuity and decrease post-operative swelling in diabetic patients requiring cataract extraction as compared to the conventional treatment of laser following cataract surgery. The subjects will be followed for 11 visits over 3 year. Visits will occur at screening,1, 3,6,9,12,18,24,30 and 36 months post surgery.

Eligibility Criteria

Inclusion Criteria

visually significant cataracts
pre-operative visual acuity 20/50 or worse
pre-operative optical coherence tomography (OCT) showing at least 250 microns central foveal thickness.

Exclusion Criteria

macular ischemia
vitreomacular traction
macular hole

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00229931). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.