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| Sponsored by: |
Dean Health System |
|---|---|
| Information provided by: | Dean Health System |
| ClinicalTrials.gov Identifier: | NCT00478764 |
Purpose
The use of one dose of an antibiotic and steroid injected into the eye at the end of cataract surgery is as safe and effective as the post operative use of eyedrops after cataract surgery.
| Condition | Intervention |
|---|---|
|
Cataract |
Drug: intraocular triamcinolone and gatifloxicin |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Intracameral Use of Triamcinolone and Gatifloxacin Versus Standard Postoperative Steroid and Antibiotic Eye Drops After Cataract Surgery |
| Enrollment: | 41 |
| Study Start Date: | March 2006 |
| Study Completion Date: | April 2007 |
This prospective randomized controlled trial included 80 eyes of 40 patients having routine phacoemulsification of cataract. Patients between 40 and 80 years of age who met enrollment criteria, required cataract surgery in both eyes, and agreed to participate, were enrolled in the study over a nine month period in 2006 at the office of one cataract surgeon. Eyes were randomly assigned to receive either the eye drop or injection protocol on the initial consultative visit. All surgery was preformed by one surgeon (JGS) using topical anesthesia, the Infiniti phacoemulsification system (Alcon) and an Acrysof SN60WF (Alcon) intraocular lens. The fellow eye was operated upon using the same technique and instrumentation two weeks later and was assigned to the group opposite the first eye. All eyes were examined by the operating surgeon at days 1, 8, 15, 30 and 90 postoperatively with uncorrected visual acuity, best corrected visual acuity, intraocular pressure, corneal edema, anterior chamber cell and flare recorded.
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Wisconsin | |
| Davis Duehr Dean Baraboo | |
| Baraboo, Wisconsin, United States, 53913 | |
| Principal Investigator: | Jonathan G Stock, MD | Dean Health Systems |
More Information
| Study ID Numbers: | IOSS |
| Study First Received: | May 24, 2007 |
| Last Updated: | May 24, 2007 |
| ClinicalTrials.gov Identifier: | NCT00478764 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
intraocular triamcinolone gatifloxicin inflammation visual acuity |
|
Anti-Inflammatory Agents Immunologic Factors Hormone Antagonists Eye Diseases Hormones, Hormone Substitutes, and Hormone Antagonists Lens Diseases Triamcinolone diacetate Tetrahydrozoline Immunosuppressive Agents |
Hormones Glucocorticoids Inflammation Gatifloxacin Triamcinolone hexacetonide Anti-Bacterial Agents Triamcinolone Acetonide Cataract Triamcinolone |
|
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Eye Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Enzyme Inhibitors Lens Diseases Triamcinolone diacetate |
Immunosuppressive Agents Glucocorticoids Hormones Pharmacologic Actions Triamcinolone hexacetonide Triamcinolone Acetonide Cataract Therapeutic Uses Triamcinolone |
