Triamcinolone vs. Laser for Diabetic Macular Edema

NCT00229931 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2023-12-28

Study results available
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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.

Conditions

Interventions

DRUG

Triamcinolone acetonide

4mg of intravitreal triamcinolone at time of cataract surgery with option to repeat at one month if no response

PROCEDURE

laser

Laser treatment 1 month after cataract surgery with option to repeat once if no improvement.

Sponsors & Collaborators

  • University of Oklahoma

    lead OTHER

Principal Investigators

  • Robert E Leonard, MD · Dean A. McGee Eye Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00229931 on ClinicalTrials.gov