Intraocular Steroid After Cataract Surgery Study
Information source: Dean Health System
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cataract
Intervention: intraocular triamcinolone and gatifloxicin (Drug)
Phase: N/A
Status: Completed
Sponsored by: Dean Health System Official(s) and/or principal investigator(s):
Jonathan G Stock, MD, Principal Investigator, Affiliation: Dean Health Systems
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.
Clinical Details
Official title: Intracameral Use of Triamcinolone and Gatifloxacin Versus Standard Postoperative Steroid and Antibiotic Eye Drops After Cataract Surgery
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: visual acuity
Secondary outcome: intraocular inflammation
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
Minimum age: 40 Years.
Maximum age: 80 Years.
Gender(s): Both.
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.
Locations and Contacts
Davis Duehr Dean Baraboo, Baraboo, Wisconsin 53913, United States
Additional Information
Related 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.
Starting date: March 2006
Last updated: May 24, 2007
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