MyopiaNCT00413673
Initial Evaluation of Photorefractive Keratectomy in U.S. Army Personnel
A study testing PRK in people with Myopia, run by Walter Reed Army Medical Center at 1 site in United States.
Trial summary
The objective of this study is to conduct a prospective clinical trial to evaluate the safety and efficacy fo the VISX Excimer Laser system for the treatment of naturally occurring low to moderate myopia, with or without low levels of astigmatism, in U.S. Army personnel. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- PRK
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2001to Mar 2008
- 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 adults with access to medical care at Walter Reed Health Care System.
- Age 21 years or older.
- Spherical equivalent of the manifest refractive error between -1.0 to -6.0 diopters (D), inclusive, with no more than 3.0D of cylinder. The absolute value of the cylinder (expressed in minus cylinder) will be limited such that the short axis of the elliptical ablation will be no smaller than 4.9mm. The following specifies the maximum cylinder for a given spherical component of the manifest refraction:
- Spherical component / Maximum cylinder
- 1.0D / -0.5D
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- 2.0D / -1.0D
- 3.0D / -1.5D
- 4.0D / -2.0D
- 5.0D / -2.5D
- 6.0D / -3.0D
- Corrected vision of at least 20/20
- Soft contact lens users must havE removed their lenses at least two weeks prior to baseline measurements.
- Hard contact lens users (PMMA or rigid gas permeable lenses) must have removed their lenses at least four weeks prior to baseline measurements. At least two weekly manifest refractions and keratometry measurements will be required in this interval. The last two measurements must not vary by more than 0.50D in any meridian.
- Patients undergoing orthokeratology must have their lenses removed at least 6 months prior to the baseline examination. At least two monthly manifest refractions and keratometry measurements taken after the third month out of lenses must not vary by more than 0.50D in any meridian.
- Refractive stability must be documented by previous refractions. Spherical and cylindrical portion of the manifest refraction must not have varied by more than 0.50D over the previous 12 months.
- Exhibits strong motivation for keeping the follow-up visits.
- Available for evaluation at Walter Reed during the two-year follow-up period.
- Service members must have their command approval to participate in the study.
- Access to transportation to meet follow-up requirements.
Who cannot join
- Residual, recurrent or active ocular diseases or corneal abnormalities in either eye such as iritis, uveitis, keratoconjunctivitis sicca, herpetic keratitis, vernal conjunctivitis, lagophthalmos, corneal scarring, glaucoma, previous steroid responder, occludable chamber angles, visually significant cataracts.
- Either one or both eyes suffering from chronic dryness.
- Taking any systemic medications that may affect wound healing such as corticosteroids or antimetabolites.
- Patient corneal neovascularization within one mm of the ablation zone.
- History of any previous eye surgery, including previous refractive surgery.
- Best corrected visual acuity of less than 20/20.
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- Progressive myopia or keratoconus.
- Any systemic disease that may affect wound healing, such as connective tissue disorders (rheumatoid arthritis, systemic lupus erythematosus, etc.), diabetes, or severe atopic disease.
- Any physical or mental impairment that would preclude participation in any of the examinations.
- For contact lens users there must be no evidence of contact lens corneal warpage on computerized topography.
- Currently on flight status or projected to be on flight status within ten years.
- Pregnant or breast-feeding an infant. Women of childbearing age must take a urine blood pregnancy test before starting this study
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
The objective of this study is to conduct a prospective clinical trial to evaluate the safety and efficacy fo the VISX Excimer Laser system for the treatment of naturally occurring low to moderate myopia, with or without low levels of astigmatism, in U.S. Army personnel.
- Conditions
- Myopia
- Being tested
- PRK
- Keywords
- Naturally occurring low to moderate myopia, with or without low levels of astigmatism in U.S. Army personnel
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRKProcedure or surgery
PRK
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | PRK Receives: Procedure: PRK |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety and efficacy of PRK
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 posted20 Dec 2006 (estimated)
- Study startAug 2001
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Walter Reed Army Medical Center
- Sponsor type
- US federal agency
- Investigators
- KRAIG S. BOWER, MD, Principal investigator, Walter Reed Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00413673
- Sponsor's protocol ID
- WRAMC WU # 2335-99
- Status last verified
- Nov 2007
- First submitted
- 19 Dec 2006
- Last updated
- 1 Apr 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Evaluation of Photorefractive Keratectomy in U.S. Army Personnel
- ClinicalTrials.gov ID
- NCT00413673
- Acronym / sponsor ID
- WRAMC WU # 2335-99
- Conditions
- Myopia
- Keywords
- Naturally occurring low to moderate myopia, with or without low levels of astigmatism in U.S. Army personnel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Walter Reed Army Medical CenterUS federal agency
- Study start
- Aug 2001
- Study completion
- Mar 2008
- First posted
- 20 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 objective of this study is to conduct a prospective clinical trial to evaluate the safety and efficacy fo the VISX Excimer Laser system for the treatment of naturally occurring low to moderate myopia, with or without low levels of astigmatism, in U.S. Army personnel.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: PRKPRK |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Informed consent.
- Normal, healthy active adults with access to medical care at Walter Reed Health Care System.
- Age 21 years or older.
- Spherical equivalent of the manifest refractive error between -1.0 to -6.0 diopters (D), inclusive, with no more than 3.0D of cylinder. The absolute value of the cylinder (expressed in minus cylinder) will be limited such that the short axis of the elliptical ablation will be no smaller than 4.9mm. The following specifies the maximum cylinder for a given spherical component of the manifest refraction:
- Spherical component / Maximum cylinder
Key exclusion criteria (12 listed)
- Residual, recurrent or active ocular diseases or corneal abnormalities in either eye such as iritis, uveitis, keratoconjunctivitis sicca, herpetic keratitis, vernal conjunctivitis, lagophthalmos, corneal scarring, glaucoma, previous steroid responder, occludable chamber angles, visually significant cataracts.
- Either one or both eyes suffering from chronic dryness.
- Taking any systemic medications that may affect wound healing such as corticosteroids or antimetabolites.
- Patient corneal neovascularization within one mm of the ablation zone.
- History of any previous eye surgery, including previous refractive surgery.
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 |
Primary outcome
safety and efficacy of PRK
Time frame: 12 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2008.
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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
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 in people with 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 20 inclusion and 12 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: finished, as of the sponsor's last update on 1 Apr 2008. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
safety and efficacy of PRK (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 1 Apr 2008.