Intraocular Steroid After Cataract Surgery Study
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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: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Intracameral Use of Triamcinolone and Gatifloxacin Versus Standard Postoperative Steroid and Antibiotic Eye Drops After Cataract Surgery |
- visual acuity [ Time Frame: 90 days ]
- intraocular inflammation [ Time Frame: 90 days ]
| 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:
- Inclusion criteria for patients to enter the study included age 40 to 80 years, clinically significant cataract in both eyes, the patient’s willingness to enter the study and have cataract surgery preformed on each eye in a sequentially within a two or three week time frame.
Exclusion Criteria:
- Exclusion criteria included a history of glaucoma, retinopathy of any type, pseudoexfoliation, other significant ocular co morbidity and systemic diabetes.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00478764
| United States, Wisconsin | |
| Davis Duehr Dean Baraboo | |
| Baraboo, Wisconsin, United States, 53913 | |
| Principal Investigator: | Jonathan G Stock, MD | Dean Health Systems |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00478764 History of Changes |
| Other Study ID Numbers: | IOSS |
| Study First Received: | May 24, 2007 |
| Last Updated: | May 24, 2007 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Dean Health System:
|
intraocular triamcinolone gatifloxicin inflammation visual acuity |
Additional relevant MeSH terms:
|
Cataract Eye Diseases Lens Diseases Triamcinolone Triamcinolone Acetonide Triamcinolone diacetate Triamcinolone hexacetonide Anti-Inflammatory Agents Enzyme Inhibitors |
Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Immunologic Factors Immunosuppressive Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015