MODERATE AND HIGH MYOPIANCT00415077
A Comparison of Photorefractive Keratectomy (PRK), PRK With Mitomycin-C and Laser Subepithelial Keratomileusis (LASEK) in the Treatment of Moderate and High Myopia
A study testing PRK, MMC PRK and LASEK in people with MODERATE AND HIGH MYOPIA, run by Walter Reed Army Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to assess whether there is a significant difference in visual outcomes or corneal haze after surface ablation for moderate and high myopia in active duty service members treated with PRK, Mitomycin-C (MMC) PRK and LASEK. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- MODERATE AND HIGH MYOPIA
- What is being tested?
- PRK, MMC PRK and LASEK
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 960 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to not given
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informed consent.
- Normal, healthy, active duty adults age 21 years or older. The lower age limit of 21 years is intended to ensure documentation of refractive stability.
- Manifest refractive spherical equivalent of greater than -4.00 diopters (D) up to -10.00 D.
- Best spectacle corrected visual acuity of 20/20 or better in both eyes.
- Demonstrated refractive stability, confirmed by clinical records. Neither the spherical nor the cylindrical portion of the refraction may have changed more than 0.50D during the 12-month period immediately preceding the baseline examination, as confirmed by clinical records.
- Both eyes must fall in the same refraction group and there must be less than 1 D difference between eyes.
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- Soft contact lens users must have removed their lenses at least 2 weeks before baseline measurements. Hard contact lens users (PMMA or rigid gas permeable lenses) must have removed their lenses at least 4 weeks prior to baseline measurements and have 2 central keratometry readings and 2 manifest refractions taken at least 1 week apart that do not differ by more than 0.50 D in either meridian.
- Access to transportation to meet the follow-up requirements.
- Available for evaluation during the 1-year follow-up period.
- Consent of the subject's command to participate in the study.
Who cannot join
- Female subjects who are pregnant, breast-feeding or intend to become pregnant during the study. Women of childbearing age will take a urine pregnancy test before starting this study.
- Residual, recurrent or active ocular diseases or corneal abnormalities in either eye such as keratoconus, iritis, uveitis, keratoconjunctivitis sicca, vernal conjunctivitis, lagophthalmos, corneal scarring, glaucoma, previous steroid responder, occludable chamber angles, visually significant cataracts.
- Medical condition(s), which, in the judgment of the investigator, may impair healing, including but not limited to: collagen vascular disease, autoimmune disease, immunodeficiency diseases, and ocular herpes zoster or simplex.
- Concurrent topical or systemic medications that may impair healing, including corticosteroids, antimetabolites, isotretinoin (Accutane), amiodarone hydrochloride (Cordarone) and/or sumatripin (Imitrex).
- Any physical or mental impairment that would preclude participation in any of the examinations.
- Prior refractive or ocular surgery.
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed Army Medical Center, Center For Refractive Surgery
Washington D.C., District of Columbia, 20307
About this study
Official title: A Prospective Comparison of Photorefractive Keratectomy (PRK), PRK With Mitomycin-C and Laser Subepithelial Keratomileusis (LASEK) in the Treatment of Moderate and High Myopia
The purpose of this study is to assess whether there is a significant difference in visual outcomes or corneal haze after surface ablation for moderate and high myopia in active duty service members treated with PRK, Mitomycin-C (MMC) PRK and LASEK.
- Conditions
- MODERATE AND HIGH MYOPIA
- Being tested
- PRK, MMC PRK, LASEK
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRKProcedure or surgery
PRK
MMC PRKProcedure or surgery
mitomycin C PRK
LASEKProcedure or surgery
LASEK
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | LASEK- laser-assisted subepithelial keratectomy Receives: Procedure: MMC PRK |
| 3 | Active comparator | Mitomycin C PRK Receives: Procedure: LASEK |
| 1 | Active comparator | PRK- Photorefractive keratectomy Receives: Procedure: PRK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy in terms of uncorrected visual acuity and post operative refraction. Safety in terms of maintenance of best spectacle corrected acuity within 2 lines of preoperative levels.
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2006 (estimated)
- Study startJun 2004
Why it stopped: Change in excimer laser systems prior to completion of study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MODERATE AND HIGH MYOPIAStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 960 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Walter Reed Army Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Madigan Army Medical Center, C.R.Darnall Army Medical Center, Blanchfield Army Community Hospital, Tripler Army Medical Center
- Investigators
- KRAIG S BOWER, MD, Principal investigator, DIRECTOR, CENTER FOR REFRACTIVE SURGERY WALTER REED ARMY MEDICAL CENTER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00415077
- Sponsor's protocol ID
- WRAMC WU# 04-23009
- Status last verified
- Jul 2010
- First submitted
- 21 Dec 2006
- Last updated
- 16 Jul 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Comparison of Photorefractive Keratectomy (PRK), PRK With Mitomycin-C and Laser Subepithelial Keratomileusis (LASEK) in the Treatment of Moderate and High Myopia
- ClinicalTrials.gov ID
- NCT00415077
- Acronym / sponsor ID
- WRAMC WU# 04-23009
- Conditions
- MODERATE AND HIGH MYOPIA
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change in excimer laser systems prior to completion of study
- Enrolment
- 960 participants (estimated)
- Lead sponsor
- Walter Reed Army Medical CenterUS federal agency
- Collaborators
- Madigan Army Medical Center, C.R.Darnall Army Medical Center, Blanchfield Army Community Hospital, Tripler Army Medical Center
- Study start
- Jun 2004
- First posted
- 22 Dec 2006 (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.
The purpose of this study is to assess whether there is a significant difference in visual outcomes or corneal haze after surface ablation for moderate and high myopia in active duty service members treated with PRK, Mitomycin-C (MMC) PRK and LASEK.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Procedure: MMC PRKLASEK- laser-assisted subepithelial keratectomy |
| 3 | Active comparator | Procedure: LASEKMitomycin C PRK |
| 1 | Active comparator | Procedure: PRKPRK- Photorefractive keratectomy |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Informed consent.
- Normal, healthy, active duty adults age 21 years or older. The lower age limit of 21 years is intended to ensure documentation of refractive stability.
- Manifest refractive spherical equivalent of greater than -4.00 diopters (D) up to -10.00 D.
- Best spectacle corrected visual acuity of 20/20 or better in both eyes.
- Demonstrated refractive stability, confirmed by clinical records. Neither the spherical nor the cylindrical portion of the refraction may have changed more than 0.50D during the 12-month period immediately preceding the baseline examination, as confirmed by clinical records.
Key exclusion criteria (6 listed)
- Female subjects who are pregnant, breast-feeding or intend to become pregnant during the study. Women of childbearing age will take a urine pregnancy test before starting this study.
- Residual, recurrent or active ocular diseases or corneal abnormalities in either eye such as keratoconus, iritis, uveitis, keratoconjunctivitis sicca, vernal conjunctivitis, lagophthalmos, corneal scarring, glaucoma, previous steroid responder, occludable chamber angles, visually significant cataracts.
- Medical condition(s), which, in the judgment of the investigator, may impair healing, including but not limited to: collagen vascular disease, autoimmune disease, immunodeficiency diseases, and ocular herpes zoster or simplex.
- Concurrent topical or systemic medications that may impair healing, including corticosteroids, antimetabolites, isotretinoin (Accutane), amiodarone hydrochloride (Cordarone) and/or sumatripin (Imitrex).
- Any physical or mental impairment that would preclude participation in any of the examinations.
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 |
|---|---|---|
| PRKPRK | Procedure or surgery | 1 |
| MMC PRKmitomycin C PRK | Procedure or surgery | 2 |
| LASEKLASEK | Procedure or surgery | 3 |
Primary outcome
Efficacy in terms of uncorrected visual acuity and post operative refraction. Safety in terms of maintenance of best spectacle corrected acuity within 2 lines of preoperative levels.
Time frame: 12 months after surgery
Results and safety
The study was stopped early (reason given: Change in excimer laser systems prior to completion of study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2010.
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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.
KRAIG S BOWER, MD principal investigator
DIRECTOR, CENTER FOR REFRACTIVE SURGERY WALTER REED ARMY MEDICAL CENTER
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRK, MMC PRK and LASEK in people with MODERATE AND HIGH MYOPIA, run by Walter Reed Army Medical Center 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 10 inclusion and 6 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: stopped early, as of the sponsor's last update on 16 Jul 2010. 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.
Are results available for this study?
The study was stopped early (reason given: Change in excimer laser systems prior to completion of 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?
Efficacy in terms of uncorrected visual acuity and post operative refraction. Safety in terms of maintenance of best spectacle corrected acuity within 2 lines of preoperative levels. (time frame: 12 months after surgery). 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 16 Jul 2010.