Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00478764
Status:
COMPLETED
Last Update Posted:
2007-05-25
First Post:
2007-05-24
Brief Title:
Intraocular Steroid After Cataract Surgery Study
Sponsor:
Dean Health System
Organization:
Dean Health System
Study Overview
Official Title:
Intracameral Use of Triamcinolone and Gatifloxacin Versus Standard Postoperative Steroid and Antibiotic Eye Drops After Cataract Surgery
Status:
COMPLETED
Status Verified Date:
2007-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None