Intraocular Steroid After Cataract Surgery Study

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00478764

First Posted: May 25, 2007

Last Update Posted: May 25, 2007

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

Dean Health System

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 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

Resource links provided by NLM:

MedlinePlus related topics: Cataract

Drug Information available for: Triamcinolone diacetate Triamcinolone acetonide Triamcinolone Triamcinolone hexacetonide

U.S. FDA Resources

Further study details as provided by Dean Health System:

Primary Outcome Measures:

visual acuity [ Time Frame: 90 days ]

Secondary Outcome Measures:

intraocular inflammation [ Time Frame: 90 days ]


Enrollment:	41
Study Start Date:	March 2006
Study Completion Date:	April 2007

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.

Eligibility

Information from the National Library of Medicine

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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

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

Publications:

Gills JP, Gills P. Effect of intracameral triamcinolone to control inflammation following cataract surgery. J Cataract Refract Surg. 2005 Aug;31(8):1670-1.


ClinicalTrials.gov Identifier:	NCT00478764 History of Changes
Other Study ID Numbers:	IOSS
First Submitted:	May 24, 2007
First Posted:	May 25, 2007
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

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