Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00324168
Status:
COMPLETED
Last Update Posted:
2018-08-01
First Post:
2006-05-05
Brief Title:
Steroids for Corneal Ulcers Trial
Sponsor:
Thomas M Lietman
Organization:
University of California San Francisco
Study Overview
Official Title:
Steroids for Corneal Ulcers Trial
Status:
COMPLETED
Status Verified Date:
2018-07
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:
SCUT
Brief Summary:
The purpose of this study is to determine whether adding topical steroids improves the outcomes of bacterial corneal ulcers especially visual acuity
Detailed Description:
Antimicrobial treatment of a bacterial corneal ulcer is generally effective in eradicating infection However successful treatment is not always associated with a good visual outcome The scarring that accompanies the resolution of infection leaves many eyes blind Some cornea specialists advocate the use of topical corticosteroids along with antibiotics in an effort to reduce immune-mediated tissue damage and scarring Others fear using steroids to reduce the corneas immune response will prolong or even exacerbate infection Ophthalmologists have been divided on this issue for more than 30 years and both approaches are acceptable according to the American Academy of Ophthalmologys Preferred Practice Patterns Evidence from animal and human reports is mixed A single randomized trial saw a non-significant benefit to steroids but was drastically underpowered 20 patients per study arm
The study is a randomized double-masked placebo-controlled trial to determine whether adding topical steroids improves the outcomes of bacterial corneal ulcers Five hundred bacterial corneal ulcers presenting to the Aravind Eye Hospitals the University of California San Francisco UCSF Proctor Foundation and the Dartmouth-Hitchcock Medical Center will be randomized to receive antibiotic plus steroid or antibiotic plus placebo Participants will be followed closely until re-epithelialization and then rechecked at three weeks three months and 12 months post enrollment A subset of patients will be contacted for a follow-up visit four years post enrollment The primary outcome is best spectacle-corrected visual acuity three months after enrollment using best spectacle-corrected enrollment visual acuity as a co-variate
A pilot study was conducted from January 2005 to August 2005 at Aravind Eye Hospital to assess the feasibility and safety and to estimate the sample size of a larger main trial Forty-two patients with culture-proven bacterial keratitis were enrolled They were treated and followed up as in the main trial up to three months from enrollment
The study is a randomized double-masked placebo-controlled trial to determine whether adding topical steroids improves the outcomes of bacterial corneal ulcers Five hundred bacterial corneal ulcers presenting to the Aravind Eye Hospitals the University of California San Francisco UCSF Proctor Foundation and the Dartmouth-Hitchcock Medical Center will be randomized to receive antibiotic plus steroid or antibiotic plus placebo Participants will be followed closely until re-epithelialization and then rechecked at three weeks three months and 12 months post enrollment A subset of patients will be contacted for a follow-up visit four years post enrollment The primary outcome is best spectacle-corrected visual acuity three months after enrollment using best spectacle-corrected enrollment visual acuity as a co-variate
A pilot study was conducted from January 2005 to August 2005 at Aravind Eye Hospital to assess the feasibility and safety and to estimate the sample size of a larger main trial Forty-two patients with culture-proven bacterial keratitis were enrolled They were treated and followed up as in the main trial up to three months from enrollment
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10EY015114-01 | NIH | None | httpsreporternihgovquickSearchU10EY015114-01 |