Back to resultsIntraocular Steroid After Cataract Surgery Study
Primary Purpose
Cataract
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
intraocular triamcinolone and gatifloxicin
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring intraocular, triamcinolone, gatifloxicin, inflammation, visual acuity
Eligibility 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.
Sites / Locations
- Davis Duehr Dean Baraboo
Outcomes
Primary Outcome Measures
visual acuity
Secondary Outcome Measures
intraocular inflammation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00478764
Brief Title
Intraocular Steroid After Cataract Surgery Study
Official Title
Intracameral Use of Triamcinolone and Gatifloxacin Versus Standard Postoperative Steroid and Antibiotic Eye Drops After Cataract Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Dean Health System
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
intraocular, triamcinolone, gatifloxicin, inflammation, visual acuity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
intraocular triamcinolone and gatifloxicin
Primary Outcome Measure Information:
Title
visual acuity
Time Frame
90 days
Secondary Outcome Measure Information:
Title
intraocular inflammation
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan G Stock, MD
Organizational Affiliation
Dean Health Systems
Official's Role
Principal Investigator
Facility Information:
Facility Name
Davis Duehr Dean Baraboo
City
Baraboo
State/Province
Wisconsin
ZIP/Postal Code
53913
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16129313
Citation
Gills JP, Gills P. Effect of intracameral triamcinolone to control inflammation following cataract surgery. J Cataract Refract Surg. 2005 Aug;31(8):1670-1. doi: 10.1016/j.jcrs.2005.07.023. No abstract available.
Results Reference
background
Learn more about this trial
Intraocular Steroid After Cataract Surgery Study
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