Steroids for Corneal Ulcers Trial

Steroids for Corneal Ulcers Trial

Sponsors

Lead Sponsor: Thomas M. Lietman

Collaborator: Aravind Eye Hospitals, India
Dartmouth-Hitchcock Medical Center
National Eye Institute (NEI)

Source University of California, San Francisco
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 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 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.

Overall Status Completed
Start Date 2006-09-01
Completion Date 2012-12-01
Primary Completion Date 2011-02-01
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Best Spectacle-corrected Visual Acuity (BSCVA) in logMAR at 3 Months, Using Best Spectacle-corrected Enrollment Visual Acuity as a Co-variate 3 months from enrollment
Secondary Outcome
Measure Time Frame
Infiltrate/Scar Size, Correcting for Infiltrate/Scar Size at Enrollment 3 months from enrollment
Best Hard Contact Lens Corrected Visual Acuity Measured in logMAR, Correcting for Best Spectacle Corrected Visual Acuity at Enrollment 3 months from enrollment
Time to Resolution of Epithelial Defect From enrollment up to 21 days
Ocular Perforations At the time of perforation
Best Spectacle-corrected Visual Acuity (BSCVA) in logMAR at 12 Months, Using Best Spectacle-corrected Enrollment Visual Acuity as a Co-variate 12 months from enrollment
Best Spectacle-corrected Visual Acuity (BSCVA) in logMAR Using MIC (Minimum Inhibitory Concentration) to Moxifloxacin as a Covariate 3 months after enrollment
Subgroup Analysis Predicting 3 Month Best Spectacle-corrected Visual Acuity (BSCVA) by Causative Organism 3 months after enrollment
Subgroup Analysis Predicting 3 Month Best Spectacle-corrected Visual Acuity (BSCVA) by Visual Acuity Group 3 months from enrollment
Subgroup Analysis of Best Spectacle-corrected Visual Acuity (BSCVA) by Categories of Infiltrate Depth 3 months from enrollment
Subgroup Analysis Predicting Best Spectacle-corrected Visual Acuity (BSCVA) as Stratified by Categories of Infiltrate/Scar Size 3 months from enrollment
Enrollment 500
Condition
Intervention

Intervention Type: Drug

Intervention Name: Antibiotics

Description: moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization

Other Name: Vigamox

Intervention Type: Drug

Intervention Name: Topical corticosteroid

Description: prednisolone phosphate 1% with preservative four times a day for 1 week, then twice a day for 1 week, and finally once a day for 1 week

Arm Group Label: 1

Intervention Type: Drug

Intervention Name: Placebo

Description: 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, then twice a day for 1 week, and finally once a day for 1 week

Arm Group Label: 2

Eligibility

Criteria:

Inclusion Criteria At Presentation: - Presence of a corneal ulcer at presentation At Enrollment: - Presence of bacteria on blood or chocolate agar culture - Antibiotic given for > 48 hours - The patient must be able to verbalize a basic understanding of the study after it is explained to the patient, as determined by physician examiner. This understanding must include a commitment to return for f/u visits. - Appropriate consent Exclusion Criteria At Presentation: - Overlying epithelial defect < 0.75 mm at its greatest width at presentation - Corneal perforation or impending perforation - Evidence of fungus on KOH, Giemsa at time of presentation - Evidence of acanthamoeba by stain - Evidence of herpetic keratitis by history or exam - Corneal scar not easily distinguishable from current ulcer - 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 - Use of systemic prednisolone during the course of the present ulcer - Age less than 16 years (before 16th birthday) - Bilateral ulcers - Previous penetrating keratoplasty - Pregnancy (by history or urine test) - Immediate steroid use necessary due to surgery or other condition At Enrollment: - Evidence of fungus on culture at time of enrollment - Absence of bacteria on blood or chocolate agar culture - Best spectacle-corrected vision worse than 6/60 in the fellow eye - Corneal perforation or descemetocele - Known allergy to study medications (steroid or preservative) - No light perception in the affected eye - Not willing to come to follow-up visits - Not willing to participate

Gender:

All

Minimum Age:

16 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Location
Facility:
Proctor Foundation, UCSF | San Francisco, California, 94143, United States
Dartmouth Hitchcock Medical Center | Lebanon, New Hampshire, 03756, United States
Aravind Eye Hospital | Coimbatore, Tamil Nadu, India
Aravind Eye Hospital | Madurai, Tamil Nadu, 625 020, India
Aravind Eye Hospital | Tirunelveli, Tamil Nadu, India
Location Countries

India

United States

Verification Date

2018-07-01

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: University of California, San Francisco

Investigator Full Name: Thomas M. Lietman

Investigator Title: Prinicpal Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: 1

Type: Active Comparator

Label: 2

Type: Placebo Comparator

Acronym SCUT
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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