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

NCT02030990 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2022-04-15

No results posted yet for this study

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.

Conditions

  • Corneal Opacity

Interventions

DRUG

Mitomycin-C

0.01% applied to cornea with a sponge during PRK

DRUG

Fluorometholone 1% topical ocular steroid

topical steroid drops applied to the cornea after PRK

Sponsors & Collaborators

  • United States Naval Medical Center, San Diego

    lead FED

Principal Investigators

  • John B Cason, M.D. · United States Naval Medical Center, San Diego

  • Donna Murdoch, Ph.D. · Navy Warfighter Refractive Surgery San Diego

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2023-01-31
Completion
2023-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02030990 on ClinicalTrials.gov