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Triamcinolone vs. Laser for Diabetic Macular Edema

Information source: University of Oklahoma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: DIABETIC MACULAR EDEMA

Intervention: Triamcinolone acetonide (Drug); laser (Procedure)

Phase: N/A

Status: Completed

Sponsored by: University of Oklahoma

Official(s) and/or principal investigator(s):
Robert E Leonard, MD, Principal Investigator, Affiliation: Dean A. McGee Eye Institute

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.

Clinical Details

Official title: The Role of Triamcinolone Injection During Cataract Extraction for Diabetic Patients With Pre-Operative Macular Edema

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Main outcome measures will be quantitative changes in OCT central thickness, visual acuity, and number of Snellen acuity lines gained/lost.

Secondary outcome: Rate of elevated intraocular pressures, retinal detachment, infection, and vitreous hemorrhage.

Detailed description: Protocol Summary: This is a randomized, prospective study comparing diabetic patients with pre-operative macular edema undergoing cataract surgery treated with either 4 mg of intravitreal triamcinolone at the time of cataract surgery or focal laser treatment 1 month following cataract surgery. Disease State: The conventional treatment for clinically significant macular edema is focal laser photocoagulation. In some diabetic patients however, the cataract often impedes fundus visualization for optimal laser treatment. In these patients focal laser treatment is deferred until after cataract surgery. Study aim: 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 macular edema in diabetic patients with pre-operative macular edema requiring cataract extraction as compared to the conventional treatment of focal laser photocoagulation following cataract surgery. Hypothesis: We propose that by injecting triamcinolone intravitreally at the time of cataract surgery in patients who have pre-operative macular edema, we will not only reduce the risk of exacerbating macular edema but also possibly improve the final visual outcome. Study Procedures: After informed consent is obtained each patient will be placed, based on a randomization scheme, into either the control group receiving the conventional focal laser treatment one month following cataract extraction or into the study group receiving the IVTA injection at the time of surgery.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Dean A. McGee Eye Institute, Oklahoma City, Oklahoma 73104, United States
Additional Information

Dean McGee Eye Institute

Starting date: November 2005
Last updated: December 2, 2014

Page last updated: August 23, 2015

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