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

NCT02030990 | Unknown Phase 2 DMC

• 1 other identifier: NMCSD.2014.0032
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.Research Design This is a single-center, prospective, comparative cohort study.
3. 3.Hypothesis There will not be a significant difference in the refractive corrections amongst the treatment groups, 12 months after surgery.
4. 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

Keywords

photorefractive keratectomy; corneal haze; mitomycin-C; postoperative steroids

Outcome Measures

Primary Outcomes (1)

• Refractive Error

  Objective refractive error with Wavescan Aberrometry

  12 months

Secondary Outcomes (3)

• Refractive Error

  12 months

• Corneal haze

  12 months

• Corneal haze

  12 months

Study Arms (3)

Mitomycin-C; 3 week FML steroid taper

EXPERIMENTAL

Mitomycin-C 0.01% will be administered intraoperatively during PRK for 15 seconds. The patient will take a 3 week fluorometholone 1% topical steroid taper.

Drug: Mitomycin-C; Drug: Fluorometholone 1% topical ocular steroid

Mitomycin-C; 1 week FML steroid taper

EXPERIMENTAL

Mitomycin-C 0.01% will be administered intraoperatively during PRK for 15 seconds. The patient will take a 1 week of fluorometholone 1% topical steroid.

Drug: Mitomycin-C; Drug: Fluorometholone 1% topical ocular steroid

No mitomycin-C; 8 week FML steroid taper

ACTIVE COMPARATOR

No mitomycin-C will be administered during the procedure. Instead a sham application of salt solution will be given for 15 seconds. The patient will take 8 weeks of topical fluorometholone 1% topical steroid drop taper.

Drug: Fluorometholone 1% topical ocular steroid

Interventions

Mitomycin-C DRUG

0.01% applied to cornea with a sponge during PRK

Also known as: MMC

Mitomycin-C; 1 week FML steroid taper; Mitomycin-C; 3 week FML steroid taper

Fluorometholone 1% topical ocular steroid DRUG

topical steroid drops applied to the cornea after PRK

Also known as: FML

Mitomycin-C; 1 week FML steroid taper; Mitomycin-C; 3 week FML steroid taper; No mitomycin-C; 8 week FML steroid taper

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Active duty male or female, of any race, and at least 21 years old at the time of the pre-operative examination, and have signed an informed consent. The lower age limit of 21 is intended to ensure documentation of refractive stability.
• Manifest spherical equivalent (MSE) from +3.00 D to -11.0D with refractive cylinder of up to 3.00 D.
• Best spectacle corrected visual acuity of 20/25 or better in both eyes.
• Stable spectacle refraction, confirmed by clinical records. Neither the spherical nor the cylindrical portion of the refraction may have changed more than 0.50 D during the six-month period immediately preceding the baseline examination for myopic patients and 0.75 for hyperopic patients.
• Contact lens use: Soft contact lenses must have been removed at least two (2) weeks prior to baseline measurements. Hard contact lens users (PMMA or rigid gas permeable lenses) must have removed their lenses at least four (4) weeks prior to baseline measurements.
• Strong motivation for attending the follow-up visits and orders to remain in the area for the duration of at least twelve months of follow up.
• Consent of the subject's command to participate in the study.
• Access to transportation to meet follow up requirements.

You may not qualify if:

• Aviators.
• Female subjects who are pregnant, breast-feeding, or intend to become pregnant during the course of the study.
• Concurrent topical or systemic medications which may impair healing, including corticosteroids, antimetabolites, isotretinoin, (Accutane™), amiodarone hydrochloride (Cordarone™), and/or sumatriptan (Imitrex™).
• Medical conditions which, in the judgment of the investigator, may impair healing, including but not limited to thyroid disorders and diabetes.
• Active ophthalmic disease, neovascularization of the cornea within 1 mm of the intended ablation zone, or lens opacity.
• Evidence of glaucoma or an intraocular pressure greater than 22 mm Hg at baseline.
• Evidence of keratoconus, corneal irregularity, or abnormal videokeratography in either eye.
• Patients with known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course.
• Any physical or mental impairment which would preclude participation in any of the examinations, such as inability to give verbal responses to eye charts.

Sponsors & Collaborators

• United States Naval Medical Center, San Diego: lead

Study Sites (1)

Navy Warfighter Refractive Surgery Center

San Diego, California, 92134, United States

Location

MeSH Terms

Conditions

Corneal Opacity

Interventions

Mitomycin; Fluorometholone

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• John B Cason, M.D.

  United States Naval Medical Center, San Diego

  PRINCIPAL INVESTIGATOR

• Donna Murdoch, Ph.D.

  Navy Warfighter Refractive Surgery San Diego

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD., CDR US Navy

Study Record Dates

• First Submitted: December 20, 2013
• First Posted: January 9, 2014
• Study Start: August 1, 2014
• Primary Completion: January 1, 2023
• Study Completion: July 1, 2023
• Last Updated: April 15, 2022

Record last verified: 2022-04

Locations

US (1)