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| Sponsor: | University of Oklahoma |
|---|---|
| Information provided by: | University of Oklahoma |
| ClinicalTrials.gov Identifier: | NCT00229931 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
DIABETIC MACULAR EDEMA |
Drug: Triamcinolone acetonide Procedure: laser |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Role of Triamcinolone Injection During Cataract Extraction for Diabetic Patients With Pre-Operative Macular Edema |
| Estimated Enrollment: | 40 |
| Study Start Date: | November 2005 |
| Estimated Study Completion Date: | May 2012 |
| Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Laser therapy
If randomized to laser therapy at time of cataract surgery, laser therapy will be performed one month after cataract surgery. If macular edema does not respond an additional laser therapy will be performed. If macular edema persists after 2 lasers, then IVTA will be administered as per standard of care.
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Procedure: laser
Laser treatment 1 month after cataract surgery with option to repeat once if no improvement.
Other Name: focal laser photocoagulation
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Active Comparator: Triamcinolone therapy
At time of cataract surgery, will have IVTA injection. If macular edema does not show improvement at 1 month, then can have repeat IVTA injection. If the macular edema is stil not improved after 2nd injection, participant will be considered "treatment failure" and will be given the option to have laser therapy.
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Drug: Triamcinolone acetonide
4mg of intravitreal triamcinolone at time of cataract surgery with option to repeat at one month if no response
Other Name: Kenalog
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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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| Responsible Party: | Robert Leonard, MD/PI, Dean A. McGee Eye Institute |
| ClinicalTrials.gov Identifier: | NCT00229931 History of Changes |
| Other Study ID Numbers: | IVTA - DME |
| Study First Received: | September 28, 2005 |
| Last Updated: | July 8, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
CATARACT EXTRACTION MACULAR EDEMA DIABETES FOCAL LASER TRIAMCINOLONE |
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Edema Macular Edema Signs and Symptoms Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Triamcinolone hexacetonide Triamcinolone Acetonide Triamcinolone Triamcinolone diacetate |
Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Immunosuppressive Agents Immunologic Factors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
