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B. W. Davies, V. Panday, C. Reilly, M. Caldwell; Topical Immunomodulatory Il-1 Receptor Antagonist Therapy to Determine the Effect on Corneal Healing After Photorefractive Keratectomy in New Zealand White Rabbits (Oryctolagus Cunniculus). Invest. Ophthalmol. Vis. Sci. 2010;51(13):2853.
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To compare topical Interleukin-1 receptor antagonist (IL-1ra) against steroid treatment following photorefractive keratectomy (PRK).
This study is an IRB approved, randomized, blinded study. Following standard PRK, 48 eyes of 24 rabbits were divided into five arms: four treatment arms and one control arm. The right eye of each rabbit served as the treatment eye, while the left eye served as a control. Eyes in treatment arms were randomized to receive either Fluoromethalone 0.1% qid (standard steroid treatment), or 2.5mg, 1.25mg, or 0.25mg of IL-1ra therapy qid (experimental therapy). Control eyes received only Vigamox and Systane. Primary outcome measures included weekly evaluation of objective haze formation using Pentacam technology, subjective haze formation, and time to corneal re-epithelization, as well as histological exam for foam layer thickness at post-op week 7.
There was no difference among treatment groups in time to re-epithelization. The IL-1ra treatments groups showed a statistically significant reduction in haze formation (p<0.0001, rmANOVA) on Pentacam evaluation at 3 weeks post-surgery compared to the control group. This effect was comparable to the steroid treatment group. There was also a statistically significant effect of treatment group on subjective haze evaluation at weeks 4 and 5 (p<0.05, rmANOVA), but this effect became insignificant when the steroid group was not included in the evaluation. In addition, there was no statistically significant difference in histologic foam layer thickness among treatment groups (p=0.997).
IL-1ra therapy may be an alternative to steroid treatment following PRK. Limitations of this study include the use of non-human subjects as well as small study size. Further studies are needed to determine the efficacy and side effect profile of topical IL-1ra in human eyes.
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