Intraocular Steroid After Cataract Surgery Study

Not Applicable

Completed

• Conditions: Cataract

• Registration Number: NCT00478764
• Lead Sponsor: Dean Health System

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.

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 Timeline

• Study Start: 2006-03
• Study Completion: 2007-04
• Status Verified: 2007-05
• Study First Submitted: 2007-05-24
• Study First Submitted QC: 2007-05-24
• Last Update Submitted: 2007-05-24
• Study First Posted: 2007-05-25
• Last Update Posted: 2007-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
visual acuity	90 days

Secondary Outcome Measures

Name	Time	Method
intraocular inflammation	90 days

Trial Locations

Locations (1)

Davis Duehr Dean Baraboo; 🇺🇸 Baraboo, Wisconsin, United States