Intraocular Steroid After Cataract Surgery Study

Cataract Clinical Trial

Official title:

Intracameral Use of Triamcinolone and Gatifloxacin Versus Standard Postoperative Steroid and Antibiotic Eye Drops After Cataract Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00478764
• Other study ID #: IOSS
• Status: Completed
• Phase: N/A
• First received: May 24, 2007
• Last updated: May 24, 2007
• Start date: March 2006
• Est. completion date: April 2007

Study information

• Verified date: May 2007
• Source: Dean Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: April 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Capsule Opacification
• Cataract

Intervention

Drug:
• intraocular triamcinolone and gatifloxicin

Locations

Country	Name	City	State
United States	Davis Duehr Dean Baraboo	Baraboo	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Dean Health System

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual acuity		90 days
Secondary	intraocular inflammation		90 days