The Use of MMC During PRK and Its Effect on Postoperative Topical Steroid Requirements
Status:
Active, not recruiting
Trial end date:
2022-07-01
Target enrollment:
Participant gender:
Summary
1. Purpose To evaluate the use of mitomycin-C (MMC) as an intraoperative adjunct during
photorefractive keratectomy (PRK), its effect on postoperative healing and its ability
to reduce the postoperative topical steroid course after the surgery.
2. Research Design This is a single-center, prospective, comparative cohort study.
3. Hypothesis There will not be a significant difference in the refractive corrections
amongst the treatment groups, 12 months after surgery.
4. Objectives The primary study objective is to compare the effect of intraoperative MMC
and a postoperative short topical steroid taper of 3 weeks, intraoperative MMC and a
rapid topical steroid taper of 1 week, and a more commonly accepted postoperative
regimen of a 2 month long topical steroid taper without any intraoperative MMC. The
primary endpoint evaluated will be objective estimates of refractive error (WaveScan
WaveFront™ System) at 12 months post-surgery. Secondarily, the extent of haze formation
will be evaluated objectively using densitometry maps generated by automated Scheimpflug
imaging of the cornea (Pentacam®). Furthermore, the subjective vision from the patients'
perspective will be evaluated by questionnaires.