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Intraocular Steroid After Cataract Surgery Study

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ClinicalTrials.gov Identifier: NCT00478764
Recruitment Status : Completed
First Posted : May 25, 2007
Last Update Posted : May 25, 2007
Sponsor:
Information provided by:
Dean Health System

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Cataract Drug: intraocular triamcinolone and gatifloxicin Not Applicable

Detailed Description:
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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intracameral Use of Triamcinolone and Gatifloxacin Versus Standard Postoperative Steroid and Antibiotic Eye Drops After Cataract Surgery
Study Start Date : March 2006
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. visual acuity [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. intraocular inflammation [ Time Frame: 90 days ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00478764


Locations
United States, Wisconsin
Davis Duehr Dean Baraboo
Baraboo, Wisconsin, United States, 53913
Sponsors and Collaborators
Dean Health System
Investigators
Principal Investigator: Jonathan G Stock, MD Dean Health Systems
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

ClinicalTrials.gov Identifier: NCT00478764     History of Changes
Other Study ID Numbers: IOSS
First Posted: May 25, 2007    Key Record Dates
Last Update Posted: May 25, 2007
Last Verified: May 2007

Keywords provided by Dean Health System:
intraocular
triamcinolone
gatifloxicin
inflammation
visual acuity

Additional relevant MeSH terms:
Cataract
Capsule Opacification
Lens Diseases
Eye Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
 Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action