Intraocular Steroid After Cataract Surgery Study - Full Text View

Sponsor:	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:	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

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics 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

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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. No abstract available.

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
Lens Diseases
Eye Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
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

ClinicalTrials.gov processed this record on February 09, 2012