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Sponsored by: |
Dean A. McGee Eye Institute |
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Information provided by: | Dean A. McGee Eye Institute |
ClinicalTrials.gov Identifier: | NCT00229931 |
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 |
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Diabetic Macular Edema |
Drug: Triamcinolone acetonide Procedure: Focal laser |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study |
Official Title: | The Role of Triamcinolone Injection During Cataract Extraction for Diabetic Patients With Pre-Operative Macular Edema |
Estimated Enrollment: | 40 |
Study Start Date: | October 2005 |
Estimated Study Completion Date: | October 2007 |
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 older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lisa M Ogilbee, BS, CCRC | 405-271-6307 ext 51163 | lisa-ogilbee@dmei.org |
Contact: Connie J Dwiggins, COA | 405-271-6307 ext 51167 | connie-dwiggins@dmei.org |
United States, Oklahoma | |
Dean A. McGee Eye Institute | |
Oklahoma City, Oklahoma, United States, 73104 |
Principal Investigator: | Robert E Leonard, MD | Dean A. McGee Eye Institute |
Study ID Numbers: | IVTA - DME |
Study First Received: | September 28, 2005 |
Last Updated: | September 28, 2005 |
ClinicalTrials.gov Identifier: | NCT00229931 History of Changes |
Health Authority: | United States: Food and Drug Administration |
CATARACT EXTRACTION MACULAR EDEMA DIABETES FOCAL LASER TRIAMCINOLONE |
Anti-Inflammatory Agents Immunologic Factors Hormone Antagonists Eye Diseases Hormones, Hormone Substitutes, and Hormone Antagonists Diabetes Mellitus Edema Macular Degeneration Retinal Degeneration Triamcinolone diacetate |
Immunosuppressive Agents Hormones Glucocorticoids Triamcinolone hexacetonide Macular Edema Signs and Symptoms Triamcinolone Acetonide Cataract Triamcinolone Retinal Diseases |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Eye Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Edema Macular Degeneration Retinal Degeneration Enzyme Inhibitors Triamcinolone diacetate |
Immunosuppressive Agents Hormones Glucocorticoids Pharmacologic Actions Triamcinolone hexacetonide Macular Edema Signs and Symptoms Triamcinolone Acetonide Therapeutic Uses Triamcinolone Retinal Diseases |