Steroids for Corneal Ulcers Trial (SCUT)

• To determine whether adding topical steriods to antiobiotic treatment improves the outcomes of bacterial corneal ulcers, especially visual acuity.

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 corneal 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 cornea's 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 Ophthalmology's Preferred Practice Patterns. Evidence from animal model and human studies 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 to antibiotic treatment improves the outcomes of bacterial corneal ulcers. Bacterial corneal ulcers presenting to the Aravind Eye Hospital, the UCSF Proctor Foundation, and the Dartmouth-Hitchcock Medical Center will be randomized to receive antibiotic (moxifloxacin) plus steroid (prednisolone phosphate) or antibiotic plus placebo. They will be followed closely until re-epithelialization and then rechecked three weeks and three months later.

Inclusion criteria:

1. Presence of a corneal ulcer: defined as an epithelial defect with underlying corneal infiltrate and signs of acute inflammation
2. Overlying epithelial defect must be greater than 1 mm at its greatest width
3. Positive bacterial culture as per microbiological testing. Nocardia and mycobacteria will be included, but only if they grow on blood or chocolate agar
4. Appropriate consent

1. Evidence of fungus on potassium hydroxide or gram stain or culture
2. Evidence of acanthamoeba by history or exam
3. Evidence of herpetic keratitis by history or exam
4. Previous known corneal scar in the affected eye, by history or examination. Keratoconus patients will not be specifically excluded unless known to have a previous corneal scar. Note that pre-existing scars CANNOT be included in the analysis, as by definition, they would not have been entered into the study if known.
5. Vision <6/60 in the fellow eye
6. Corneal perforation or descemetocele
7. Known allergy to study medications (steroid or preservative). Note that penicillin, cephalosporin, or fluoroquinolone allergic patients will be started on alternative antibiotics at the physician's discretion, and are still eligible for the study.
8. Pregnancy (testing will be offered)
9. Inability to give consent
10. Use of a topical steroid in the affected eye during the course of the present ulcer, including use after the symptoms of the ulcer started but before presentation.
11. Use of systemic prednisone (oral or inhaled) during the course of the present ulcer
12. No light perception in the affected eye
13. Age under 16 years (before 16th birthday)
14. Bilateral ulcers
15. Previous penetrating keratoplasty will be excluded (but contact lens and LASIK-related ulcers will be included)

Patient Recruitment Status:

Recruiting. Comments:

Current Status of Study:

Ongoing. Comments:

Results:

The pilot study showed better visual acuity and smaller infiltrate/scar size but longer re-epithelialization time with steroids treatment. All the adverse outcomes took place in the placebo group. However, none of the results were statistically significant due to small sample size.

Publications

None


Clinical Centers




M. Srinivasan, M.S., D.O.
Aravind Eye Hospital
1 Anna Nagar
Madurai 625-020
Tamil Nadu
Madurai
India
Telephone: +91-452-435 6100
Fax: +91-452-253 0984
Email: vasanthi@aravind.org
URL: http://www.aravind.org

California
F. I. Proctor Foundation
95 Kirkham St.
San Francisco, CA 94143
USA


NEI Representative




Donald F. Everett, M.A.
National Eye Institute
National Institutes of Health
Suite 1300
5635 Fishers Lane MSC 9300
Bethesda, MD 20892-9300
USA
Telephone: (301) 451-2020
Fax: (301) 402-0528
Email: dfe@nei.nih.gov


Resource Centers



Collaborating Institution
Mike Zegans, M.D.
Dartmouth-Hitchcock Medical Center
One Medical Center Drive
Lebanon, NH 03756
USA
Email: Michael.E.Zegans@Dartmouth.EDU

Study Chair
Thomas M. Lietman, M.D.
University of California San Francisco
Francis I. Proctor Foundation for Research in Ophthalmology
95 Kirkham, Box 0944
San Francisco, CA 94143
USA
Telephone: (415) 476-1442
Email: tom.lietman@ucsf.edu

Last Updated: 9/7/2007