Trial record 3 of 6 for:    Open Studies | "Photorefractive Keratectomy"

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by United States Naval Medical Center, San Diego
Sponsor:
Information provided by (Responsible Party):
John Cason, United States Naval Medical Center, San Diego
ClinicalTrials.gov Identifier:
NCT02030990
First received: December 20, 2013
Last updated: January 28, 2014
Last verified: January 2014
  Purpose
  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.

Condition Intervention Phase
Corneal Opacity
Drug: Mitomycin-C
Drug: Fluorometholone 1% topical ocular steroid
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Prevention
Official Title: The Use of Intraoperative Mitomycin-C During Photorefractive Keratectomy and Its Effect on Postoperative Topical Steroid Requirements

Resource links provided by NLM:


Further study details as provided by United States Naval Medical Center, San Diego:

Primary Outcome Measures:
  • Refractive Error [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Objective refractive error with Wavescan Aberrometry


Secondary Outcome Measures:
  • Refractive Error [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Manifest refraction by patient subjective report

  • Corneal haze [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Subjective grading by slit lamp examiner

  • Corneal haze [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Subclinical objective measurement of corneal haze by Pentacam densitometry


Estimated Enrollment: 300
Study Start Date: July 2014
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mitomycin-C; 3 week FML steroid taper
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
0.01% applied to cornea with a sponge during PRK
Other Name: MMC
Drug: Fluorometholone 1% topical ocular steroid
topical steroid drops applied to the cornea after PRK
Other Name: FML
Experimental: Mitomycin-C; 1 week FML 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.
Drug: Mitomycin-C
0.01% applied to cornea with a sponge during PRK
Other Name: MMC
Drug: Fluorometholone 1% topical ocular steroid
topical steroid drops applied to the cornea after PRK
Other Name: FML
Active Comparator: No mitomycin-C; 8 week FML steroid taper
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
topical steroid drops applied to the cornea after PRK
Other Name: FML

Detailed Description:
  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, 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.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02030990

Contacts
Contact: John B Cason, M.D. 619-532-6700 john.cason@med.navy.mil
Contact: Donna Murdoch, Ph.D. 619-524-0771 donna.murdoch.ctr@med.navy.mil

Locations
United States, California
Navy Warfighter Refractive Surgery Center Not yet recruiting
San Diego, California, United States, 92134
Contact: Donna Murdoch, Ph.D.    619-524-0771    donna.murdoch.ctr@med.navy.mil   
Contact: Tyler Miles, O.D.    619-524-0771    tyler.miles@med.navy.mil   
Principal Investigator: John B Cason, M.D.         
Sponsors and Collaborators
United States Naval Medical Center, San Diego
Investigators
Principal Investigator: John B Cason, M.D. United States Naval Medical Center, San Diego
Study Director: Donna Murdoch, Ph.D. Navy Warfighter Refractive Surgery San Diego
  More Information

No publications provided

Responsible Party: John Cason, MD., CDR US Navy, United States Naval Medical Center, San Diego
ClinicalTrials.gov Identifier: NCT02030990     History of Changes
Other Study ID Numbers: NMCSD.2014.0032
Study First Received: December 20, 2013
Last Updated: January 28, 2014
Health Authority: United States: Food and Drug Administration
United States: Federal Government

Keywords provided by United States Naval Medical Center, San Diego:
photorefractive keratectomy
corneal haze
mitomycin-C
postoperative steroids

Additional relevant MeSH terms:
Corneal Opacity
Corneal Diseases
Eye Diseases
Mitomycins
Mitomycin
Fluorometholone
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Allergic Agents

ClinicalTrials.gov processed this record on September 22, 2014