Corneal OpacityPhase 2/3NCT02030990
The Use of MMC During PRK and Its Effect on Postoperative Topical Steroid Requirements
A Phase 2/3 study testing Mitomycin-C and Fluorometholone 1% topical ocular steroid in people with Corneal Opacity, run by United States Naval Medical Center, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Corneal Opacity
- What is being tested?
- Mitomycin-C and Fluorometholone 1% topical ocular steroid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Jul 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Navy Warfighter Refractive Surgery Center
San Diego, California, 92134
About this study
Official title: The Use of Intraoperative Mitomycin-C During Photorefractive Keratectomy and Its Effect on Postoperative Topical Steroid Requirements
- 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.
Read the 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.
- Conditions
- Corneal Opacity
- Being tested
- Mitomycin-C, Fluorometholone 1% topical ocular steroid
- Keywords
- photorefractive keratectomy, corneal haze, mitomycin-C, postoperative steroids
- Medical subject headings
- Corneal Opacity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitomycin-CDrug
Also called MMC
0.01% applied to cornea with a sponge during PRK
Fluorometholone 1% topical ocular steroidDrug
Also called FML
topical steroid drops applied to the cornea after PRK
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Fluorometholone 1% topical ocular steroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Refractive Error
Objective refractive error with Wavescan Aberrometry
Measured: 12 months
Secondary outcomes (3)
Refractive Error
Manifest refraction by patient subjective report
Measured: 12 months
Corneal haze
Subjective grading by slit lamp examiner
Measured: 12 months
Corneal haze
Subclinical objective measurement of corneal haze by Pentacam densitometry
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study startAug 2014
- Primary completionJan 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal OpacityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, San Diego
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, John Cason, United States Naval Medical Center, San Diego
- Investigators
- John B Cason, M.D., Principal investigator, United States Naval Medical Center, San DiegoDonna Murdoch, Ph.D., Study director, Navy Warfighter Refractive Surgery San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02030990
- Sponsor's protocol ID
- NMCSD.2014.0032
- Status last verified
- Apr 2022
- First submitted
- 20 Dec 2013
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Intraoperative Mitomycin-C During Photorefractive Keratectomy and Its Effect on Postoperative Topical Steroid Requirements
- ClinicalTrials.gov ID
- NCT02030990
- Acronym / sponsor ID
- NMCSD.2014.0032
- Conditions
- Corneal Opacity
- Keywords
- photorefractive keratectomy, corneal haze, mitomycin-C, postoperative steroids
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- United States Naval Medical Center, San DiegoUS federal agency
- Study start
- Aug 2014
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 9 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mitomycin-C; 3 week FML steroid taper | Experimental | Drug: Mitomycin-C, Drug: Fluorometholone 1% topical ocular steroidMitomycin-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; 1 week FML steroid taper | Experimental | Drug: Mitomycin-C, Drug: Fluorometholone 1% topical ocular steroidMitomycin-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; 8 week FML steroid taper | Active comparator | Drug: Fluorometholone 1% topical ocular steroidNo 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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mitomycin-CAlso: MMC0.01% applied to cornea with a sponge during PRK | Drug | Mitomycin-C; 1 week FML steroid taper, Mitomycin-C; 3 week FML steroid taper |
| Fluorometholone 1% topical ocular steroidAlso: FMLtopical steroid drops applied to the cornea after PRK | Drug | Mitomycin-C; 1 week FML steroid taper, Mitomycin-C; 3 week FML steroid taper, No mitomycin-C; 8 week FML steroid taper |
Primary outcome
Refractive Error
Time frame: 12 months
Objective refractive error with Wavescan Aberrometry
3 secondary outcomes
Refractive Error
Time frame: 12 months
Corneal haze
Time frame: 12 months
Corneal haze
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John B Cason, M.D. principal investigator
United States Naval Medical Center, San Diego
Donna Murdoch, Ph.D. study director
Navy Warfighter Refractive Surgery San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Mitomycin-C and Fluorometholone 1% topical ocular steroid in people with Corneal Opacity, run by United States Naval Medical Center, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Refractive Error (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2022.