Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00431028
Status:
TERMINATED
Last Update Posted:
2008-03-07
First Post:
2007-02-01
Brief Title:
Sub-Tenons Injection of Triamcinolone and Ciprofloxacin in a Controlled-Release System for Cataract Surgery
Sponsor:
Federal University of São Paulo
Organization:
Federal University of São Paulo
Study Overview
Official Title:
Phase III Comparative Study of a Single Intraoperative Sub-Tenons Capsule Injection of Triamcinolone and Ciprofloxacin in a Controlled-Release System Versus 1 Prednisolone and 03 Ciprofloxacin Eyedrops for Cataract Surgery
Status:
TERMINATED
Status Verified Date:
2008-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare one intraoperative sub-Tenons capsule injection of triamcinolone and ciprofloxacin in a biodegradable controlled-release system with conventional prednisolone and ciprofloxacin eye drops to treat ocular inflammation and for infection prophylaxis after cataract surgery
Detailed Description:
Topical steroids effectively control ocular inflammation but are associated with the well-recognized problems of patient compliance Injection of depot corticosteroids into sub-Tenons capsule is an established method of treating various ocular inflammatory diseases Its prolonged therapeutic effect has provided the ophthalmologist with an alternative tool for the treatment of different diseases that may be extended to the surgical arena to modulate postoperative inflammation
The use of topical antibiotic agents poses unique and challenging hurdles for drug delivery especially because recent reports have suggested that the incidence of endophthalmitis may be increasing Exploiting the permeability of the sclera subconjunctival routes may offer a more promising alternative for enhanced drug delivery and tissue targeting compared with topical routes In theory the combination of an antibiotic with a steroid in a controlled-release system delivered transscleral could be feasible after cataract surgery to achieve several clinical objectives ie eliminate topical medications enhance patient compliance improve drug bioavailability and protect the patient from infection
The use of topical antibiotic agents poses unique and challenging hurdles for drug delivery especially because recent reports have suggested that the incidence of endophthalmitis may be increasing Exploiting the permeability of the sclera subconjunctival routes may offer a more promising alternative for enhanced drug delivery and tissue targeting compared with topical routes In theory the combination of an antibiotic with a steroid in a controlled-release system delivered transscleral could be feasible after cataract surgery to achieve several clinical objectives ie eliminate topical medications enhance patient compliance improve drug bioavailability and protect the patient from infection
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