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 6 visits over 1 year. Visits will occur at screening, surgery, 1, 3, 6, and 12 months post surgery.

Condition	Intervention
Diabetic Macular Edema	Drug: Triamcinolone acetonide  Procedure: Focal laser

Further study details as provided by Dean A. McGee Eye Institute:

Primary Outcomes: Main outcome measures will be quantitative changes in OCT central thickness, visual acuity, and number of Snellen acuity lines gained/lost.
Secondary Outcomes: Rate of elevated intraocular pressures, retinal detachment, infection, and vitreous hemorrhage.
Expected Total Enrollment:  40

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  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

Please refer to this study by ClinicalTrials.gov identifier  NCT00229931

Lisa M Ogilbee, BS, CCRC      405-271-6307  Ext. 51163    lisa-ogilbee@dmei.org
Connie J Dwiggins, COA      405-271-6307  Ext. 51167    connie-dwiggins@dmei.org

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

Study chairs or principal investigators

Robert E Leonard, MD,  Principal Investigator,  Dean A. McGee Eye Institute   

Study ID Numbers:  IVTA - DME
Last Updated:  December 8, 2005
Record first received:  September 28, 2005
ClinicalTrials.gov Identifier:  NCT00229931
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10