Clinical Trial: The Use of MMC During PRK and Its Effect on Postoperative Topical Steroid Requirements

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: The Use of Intraoperative Mitomycin-C During Photorefractive Keratectomy and Its Effect on Postoperative Topical Steroid Requirements

Brief 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.

Detailed 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 questionnaire.
  5. Methodology At the Navy Refractive Surgery Center San Diego (NRSC SD), a total of 300 patients will be enrolled and randomly assigned to three cohorts. PRK will be performed in a standard fashion for all treatment groups. In the first two groups, intraoperative MMC 0.01% for a contact time of 15 seconds will be utilized. During the postoperative period, the first cohort will use the short steroid taper and the second cohort will use the rapid steroid taper. The third cohort will not receive any intraoperative MMC and will self-administer postoperative steroids, taperi
    Sponsor: United States Naval Medical Center, San Diego

    Current Primary Outcome: Refractive Error [ Time Frame: 12 months ]

    Objective refractive error with Wavescan Aberrometry


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Refractive Error [ Time Frame: 12 months ]
      Manifest refraction by patient subjective report
    • Corneal haze [ Time Frame: 12 months ]
      Subjective grading by slit lamp examiner
    • Corneal haze [ Time Frame: 12 months ]
      Subclinical objective measurement of corneal haze by Pentacam densitometry


    Original Secondary Outcome: Same as current

    Information By: United States Naval Medical Center, San Diego

    Dates:
    Date Received: December 20, 2013
    Date Started: August 2014
    Date Completion: January 2019
    Last Updated: December 7, 2016
    Last Verified: December 2016