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 thus scarring. Others fear that using steroids to reduce the cornea's immune response will prolong or even exacerbate infection. Evidence from animal and human reports is mixed. No single referral center in the United States has the volume necessary to support an adequate trial. We propose to perform a clinical trial evaluating the efficacy of steroids at the Aravind Eye Hospital in Madurai, India. This center receives 3-7 bacterial cornea ulcers per day and has the administrative, medical, and microbiological facilities necessary to perform the study. Since the bacterial pathogens seen in corneal ulcer patients at Aravind are similar to those seen in the United States, we believe that Aravind is a logical and cost-effective site to study the role of steroids in the treatment of bacterial keratitis, and will provide results relevant to the treatment of patients in both India and the United States. At the advice of reviewers, two parallel sites in the U.S. (the Proctor Foundation and Dartmouth Medical School) will be added to provide confirmatory data, and to highlight the differences in American and South Indian ulcers. Long-term goal: Can immunosuppressive agents improve outcomes in infectious corneal ulcers? The Specific Aims (and short-term goals), a randomized, placebo-controlled clinical trial: 1) To determine whether the addition of topical steroids to the treatment of a bacterial corneal ulcer improves post-treatment visual acuity. 2) To determine whether the addition of topical steroids results in a higher frequency of adverse outcomes. 3) To determine whether outcomes depend on the organism. ? ?

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10EY015114-03
Application #
7281194
Study Section
Special Emphasis Panel (ZEY1-VSN (06))
Program Officer
Everett, Donald F
Project Start
2005-09-30
Project End
2009-08-31
Budget Start
2007-09-01
Budget End
2008-08-31
Support Year
3
Fiscal Year
2007
Total Cost
$579,707
Indirect Cost
Name
University of California San Francisco
Department
Ophthalmology
Type
Organized Research Units
DUNS #
094878337
City
San Francisco
State
CA
Country
United States
Zip Code
94143
Zegans, Michael E; DiGiandomenico, Antonio; Ray, Kathryn et al. (2016) Association of Biofilm Formation, Psl Exopolysaccharide Expression, and Clinical Outcomes in Pseudomonas aeruginosa Keratitis: Analysis of Isolates in the Steroids for Corneal Ulcers Trial. JAMA Ophthalmol 134:383-9
Hammond, John H; Hebert, Wesley P; Naimie, Amanda et al. (2016) Environmentally Endemic Pseudomonas aeruginosa Strains with Mutations in lasR Are Associated with Increased Disease Severity in Corneal Ulcers. mSphere 1:
Ray, Kathryn J; Srinivasan, Muthiah; Mascarenhas, Jeena et al. (2014) Early addition of topical corticosteroids in the treatment of bacterial keratitis. JAMA Ophthalmol 132:737-41
McClintic, Scott M; Prajna, Namperumalsamy V; Srinivasan, Muthiah et al. (2014) Visual outcomes in treated bacterial keratitis: four years of prospective follow-up. Invest Ophthalmol Vis Sci 55:2935-40
Srinivasan, Muthiah; Mascarenhas, Jeena; Rajaraman, Revathi et al. (2014) Visual recovery in treated bacterial keratitis. Ophthalmology 121:1310-1
Srinivasan, Muthiah; Mascarenhas, Jeena; Rajaraman, Revathi et al. (2014) The steroids for corneal ulcers trial (SCUT): secondary 12-month clinical outcomes of a randomized controlled trial. Am J Ophthalmol 157:327-333.e3
Borkar, Durga S; Acharya, Nisha R; Leong, Chelsia et al. (2014) Cytotoxic clinical isolates of Pseudomonas aeruginosa identified during the Steroids for Corneal Ulcers Trial show elevated resistance to fluoroquinolones. BMC Ophthalmol 14:54
Ray, Kathryn J; Prajna, Lalitha; Srinivasan, Muthiah et al. (2013) Fluoroquinolone treatment and susceptibility of isolates from bacterial keratitis. JAMA Ophthalmol 131:310-3
Oldenburg, Catherine E; Lalitha, Prajna; Srinivasan, Muthiah et al. (2013) Moxifloxacin susceptibility mediates the relationship between causative organism and clinical outcome in bacterial keratitis. Invest Ophthalmol Vis Sci 54:1522-6
Borkar, Durga S; Fleiszig, Suzanne M J; Leong, Chelsia et al. (2013) Association between cytotoxic and invasive Pseudomonas aeruginosa and clinical outcomes in bacterial keratitis. JAMA Ophthalmol 131:147-53

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