search
Back to results

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

Primary Purpose

Corneal Opacity

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Mitomycin-C
Fluorometholone 1% topical ocular steroid
Sponsored by
United States Naval Medical Center, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Corneal Opacity focused on measuring photorefractive keratectomy, corneal haze, mitomycin-C, postoperative steroids

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. 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.
  2. Manifest spherical equivalent (MSE) from +3.00 D to -11.0D with refractive cylinder of up to 3.00 D.
  3. Best spectacle corrected visual acuity of 20/25 or better in both eyes.
  4. 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.
  5. 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.
  6. 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.
  7. Consent of the subject's command to participate in the study.
  8. Access to transportation to meet follow up requirements.

Exclusion Criteria:

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

Sites / Locations

  • Navy Warfighter Refractive Surgery Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Mitomycin-C; 3 week FML steroid taper

Mitomycin-C; 1 week FML steroid taper

No mitomycin-C; 8 week FML steroid taper

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Refractive Error
Objective refractive error with Wavescan Aberrometry

Secondary Outcome Measures

Refractive Error
Manifest refraction by patient subjective report
Corneal haze
Subjective grading by slit lamp examiner
Corneal haze
Subclinical objective measurement of corneal haze by Pentacam densitometry

Full Information

First Posted
December 20, 2013
Last Updated
April 14, 2022
Sponsor
United States Naval Medical Center, San Diego
search

1. Study Identification

Unique Protocol Identification Number
NCT02030990
Brief Title
The Use of MMC During PRK and Its Effect on Postoperative Topical Steroid Requirements
Official Title
The Use of Intraoperative Mitomycin-C During Photorefractive Keratectomy and Its Effect on Postoperative Topical Steroid Requirements
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 2014 (undefined)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
United States Naval Medical Center, San Diego

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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. Research Design This is a single-center, prospective, comparative cohort study. Hypothesis There will not be a significant difference in the refractive corrections amongst the treatment groups, 12 months after surgery. 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 Description
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. Research Design This is a single-center, prospective, comparative cohort study. Hypothesis There will not be a significant difference in the refractive corrections amongst the treatment groups, 12 months after surgery. 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. 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, tapering for two months. All cohorts will be followed at 1 week, 1 month, 3 months, 6 months and 12 months after the procedure. Standard clinical measures of visual performance will be recorded. Since visually significant corneal haze is relatively rare, corneal densitometry will be used as an objective measure to detect subclinical corneal haze in addition to our usual subjective haze evaluation done by the clinical optometrists. The patients will complete a voluntary questionnaire that evaluates their subjective impression of the refractive surgery, their recovery and their outcomes. Specifically, the patient will report the use of refractive correction, usefulness of the surgery at work, dry eye complaints, and subjective appraisal of their vision.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Opacity
Keywords
photorefractive keratectomy, corneal haze, mitomycin-C, postoperative steroids

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mitomycin-C; 3 week FML steroid taper
Arm Type
Experimental
Arm Description
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.
Arm Title
Mitomycin-C; 1 week FML steroid taper
Arm Type
Experimental
Arm Description
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.
Arm Title
No mitomycin-C; 8 week FML steroid taper
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Mitomycin-C
Other Intervention Name(s)
MMC
Intervention Description
0.01% applied to cornea with a sponge during PRK
Intervention Type
Drug
Intervention Name(s)
Fluorometholone 1% topical ocular steroid
Other Intervention Name(s)
FML
Intervention Description
topical steroid drops applied to the cornea after PRK
Primary Outcome Measure Information:
Title
Refractive Error
Description
Objective refractive error with Wavescan Aberrometry
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Refractive Error
Description
Manifest refraction by patient subjective report
Time Frame
12 months
Title
Corneal haze
Description
Subjective grading by slit lamp examiner
Time Frame
12 months
Title
Corneal haze
Description
Subclinical objective measurement of corneal haze by Pentacam densitometry
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John B Cason, M.D.
Organizational Affiliation
United States Naval Medical Center, San Diego
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Donna Murdoch, Ph.D.
Organizational Affiliation
Navy Warfighter Refractive Surgery San Diego
Official's Role
Study Director
Facility Information:
Facility Name
Navy Warfighter Refractive Surgery Center
City
San Diego
State/Province
California
ZIP/Postal Code
92134
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs