MyopiaNCT01097525
Optical Quality, Threshold Target Identification, and Military Target Task Performance After Advanced Keratorefractive Surgery
A study testing WFG PRK, WFG LASIK and WFO PRK in people with Myopia and Myopic Astigmatism, run by Fort Belvoir Community Hospital at 2 sites in United States.
Trial summary
To determine the effect of two types of wavefront modalities (WFG vs. WFO) and two types of refractive surgery (PRK vs. LASIK) on visual and military task performance after laser refractive surgery. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Myopic Astigmatism
- What is being tested?
- WFG PRK, WFG LASIK and WFO PRK
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2010to Oct 2014
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal, healthy active adults with access to medical care at Walter Reed Health Care System.
- Male or female 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 years is intended to ensure documentation of refractive stability.
- Myopic spherical manifest refractive error from -1.00D up to -10.00D inclusive, with no more than 4.00D of manifest cylinder refractive error.
- Inclusion based on pre-op Central Corneal Thickness (CCT) will be assessed according to Residual Stromal Bed Thickness
- BSCVA of at least 20/20 in the study eye.
- Soft contact lens users must have removed their lenses at least two weeks prior to baseline and follow-up measurements.
Show all 13Show fewer
- Hard contact lens users (PMMA or rigid gas permeable lenses) must have removed their lenses at least four weeks prior to baseline and follow-up measurements.
- Refractive stability must be documented by previous refractions. Spherical and cylindrical portion of the manifest refraction must not have varied by more than 0.50 diopters over the previous 12 months.
- Exhibits strong motivation for keeping the follow-up visits.
- Available for evaluation at Walter Reed during the 1 year follow-up period
- If selected, willing and available to undergo testing at Ft. Belvoir during the study period.
- All service members must have a signed command authorization to receive government sponsored refractive surgery. The signed command authorization will be included in the original application.
- Access to transportation to meet follow-up requirements.
Who cannot join
- Residual, recurrent or active ocular diseases or congenital corneal abnormalities in either eye such as iritis, uveitis, keratoconjunctivitis sicca, herpetic keratitis, vernal conjunctivitis, lagophthalmos, corneal scarring, anterior basement membrane disease, recurrent erosions, glaucoma, previous steroid responder, occludable chamber angles, visually significant cataracts.
- History of any previous eye surgery or trauma, including previous refractive surgery.
- Dry eye as reflected by Schirmer's test, subjective complaints or symptoms of dry eye, findings during slit lamp exam that would be consistent with dry eye (e.g. superficial punctuate keratitis).
- Corneal thickness insufficient to allow the residual remaining stromal bed to be no less than 300 microns in each eye. The residual stromal bed thickness will be determined by subtracting both the LASIK flap thickness and depth of the ablation from the total central corneal thickness measured by pachymetry.
- Female subjects who are pregnant, breast-feeding or intend to become pregnant during the study. This is standard of care exclusion for refractive surgery at the Walter Reed Refractive Surgery Center because of the medications that are routinely given as part of the procedures. Standard of care analgesia consists of medications (e.g. narcotics) labeled as Pregnancy Category "C" by the FDA. Teratogenic effects are not known, however, physical dependence in the neonate may occur if the mother is given narcotics. Female subjects will be given a urine pregnancy test prior to participating in the study to rule out pregnancy.
- Concurrent topical or systemic medications that may impair healing, including corticosteroids, antimetabolites, isotretinoin (Accutane), amiodarone hydrochloride (Cordarone) and/or sumatripin (Imitrex).
Show all 12Show fewer
- Significant corneal neovascularization.
- Progressive myopia or keratoconus.
- 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.
- 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.
- Inability to meet the mandated follow-up visit schedule for any reason such as duty hours, impending deployments, or PCS.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
Fort Belvoir Community Hospital
Fort Belvoir, Virginia, 22060
About this study
To determine the effect of two types of wavefront modalities (WFG vs. WFO) and two types of refractive surgery (PRK vs. LASIK) on visual and military task performance after laser refractive surgery.
- Conditions
- Myopia, Myopic Astigmatism
- Being tested
- WFG PRK, WFG LASIK, WFO PRK, WFO LASIK
- Medical subject headings
- Myopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WFG PRKProcedure or surgery
WFG LASIKProcedure or surgery
WFO PRKProcedure or surgery
WFO LASIKProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Wavefront guided (WFG) PRK | Active comparator | Not described Receives: Procedure: WFG PRK |
| WFG LASIK | Active comparator | Not described Receives: Procedure: WFG LASIK |
| Wavefront optimized (WFO) PRK | Active comparator | Not described Receives: Procedure: WFO PRK |
| WFO LASIK | Active comparator | Not described Receives: Procedure: WFO LASIK |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual outcomes
Visual outcomes will be measured in terms of:
- number of eyes achieving uncorrected visual acuity (UDVA) 20/20 or better.
- number of eyes maintaining one Snellen line of corrected distance visual acuity (CDVA).
- number of eyes within 0.50 diopter of manifest spherical equivalent.
Measured: 12 months postoperatively
objective image quality
as measured by wavefront aberrometry
Measured: 12 months postoperatively
military task performance
as measured by threshold target identification and night firing range
Measured: 6 months postoperatively
visual performance
as measured by contrast sensitivity
Measured: 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionOct 2014
- Study completionOct 2014
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fort Belvoir Community Hospital
- Sponsor type
- US federal agency
- Collaborators
- Walter Reed National Military Medical Center, US Army Night Vision and Electronic Sensors Directorate
- Responsible party
- Principal investigator, LTC Bruce Rivers, Fort Belvoir Community Hospital
- Investigators
- Kraig S Bower, MD, Principal investigator, The Wilmer Eye Institute, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01097525
- Sponsor's protocol ID
- 20481
- Status last verified
- Mar 2015
- First submitted
- 31 Mar 2010
- Last updated
- 13 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Quality, Threshold Target Identification, and Military Target Task Performance After Advanced Keratorefractive Surgery
- ClinicalTrials.gov ID
- NCT01097525
- Acronym / sponsor ID
- 20481
- Conditions
- Myopia, Myopic Astigmatism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Fort Belvoir Community HospitalUS federal agency
- Collaborators
- Walter Reed National Military Medical Center, US Army Night Vision and Electronic Sensors Directorate
- Study start
- Apr 2010
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 1 Apr 2010 (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.
To determine the effect of two types of wavefront modalities (WFG vs. WFO) and two types of refractive surgery (PRK vs. LASIK) on visual and military task performance after laser refractive surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Wavefront guided (WFG) PRK | Active comparator | Procedure: WFG PRK |
| WFG LASIK | Active comparator | Procedure: WFG LASIK |
| Wavefront optimized (WFO) PRK | Active comparator | Procedure: WFO PRK |
| WFO LASIK | Active comparator | Procedure: WFO LASIK |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Normal, healthy active adults with access to medical care at Walter Reed Health Care System.
- Male or female 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 years is intended to ensure documentation of refractive stability.
- Myopic spherical manifest refractive error from -1.00D up to -10.00D inclusive, with no more than 4.00D of manifest cylinder refractive error.
- Inclusion based on pre-op Central Corneal Thickness (CCT) will be assessed according to Residual Stromal Bed Thickness
- BSCVA of at least 20/20 in the study eye.
Key exclusion criteria (12 listed)
- Residual, recurrent or active ocular diseases or congenital corneal abnormalities in either eye such as iritis, uveitis, keratoconjunctivitis sicca, herpetic keratitis, vernal conjunctivitis, lagophthalmos, corneal scarring, anterior basement membrane disease, recurrent erosions, glaucoma, previous steroid responder, occludable chamber angles, visually significant cataracts.
- History of any previous eye surgery or trauma, including previous refractive surgery.
- Dry eye as reflected by Schirmer's test, subjective complaints or symptoms of dry eye, findings during slit lamp exam that would be consistent with dry eye (e.g. superficial punctuate keratitis).
- Corneal thickness insufficient to allow the residual remaining stromal bed to be no less than 300 microns in each eye. The residual stromal bed thickness will be determined by subtracting both the LASIK flap thickness and depth of the ablation from the total central corneal thickness measured by pachymetry.
- Female subjects who are pregnant, breast-feeding or intend to become pregnant during the study. This is standard of care exclusion for refractive surgery at the Walter Reed Refractive Surgery Center because of the medications that are routinely given as part of the procedures. Standard of care analgesia consists of medications (e.g. narcotics) labeled as Pregnancy Category "C" by the FDA. Teratogenic effects are not known, however, physical dependence in the neonate may occur if the mother is given narcotics. Female subjects will be given a urine pregnancy test prior to participating in the study to rule out pregnancy.
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 |
|---|---|---|
| WFG PRK | Procedure or surgery | Wavefront guided (WFG) PRK |
| WFG LASIK | Procedure or surgery | WFG LASIK |
| WFO PRK | Procedure or surgery | Wavefront optimized (WFO) PRK |
| WFO LASIK | Procedure or surgery | WFO LASIK |
Primary outcome
visual outcomes
Time frame: 12 months postoperatively
Visual outcomes will be measured in terms of: * number of eyes achieving uncorrected visual acuity (UDVA) 20/20 or better. * number of eyes maintaining one Snellen line of corrected distance visual acuity (CDVA). * number of eyes within 0.50 diopter of manifest spherical equivalent.
objective image quality
Time frame: 12 months postoperatively
as measured by wavefront aberrometry
military task performance
Time frame: 6 months postoperatively
as measured by threshold target identification and night firing range
visual performance
Time frame: 12 months postoperatively
as measured by contrast sensitivity
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 13 Mar 2015.
Related trials for Myopia
Enrolling by invitation
Therapeutic Efficacy of Different Repeated Low-Intensity Red Light Devices and Different Usage Frequencies
Myopia
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruitingPhase 4
Odyssey Evaluation in Post LASIK Patients
Cataract
RecruitingPhase 3
A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control
Myopia
Recruiting
Evaluation of Orthokeratology Lenses With a 5MM Optic Zone Diameter
Myopia, Astigmatism
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
The Wilmer Eye Institute, Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WFG PRK, WFG LASIK and WFO PRK in people with Myopia and Myopic Astigmatism, run by Fort Belvoir Community Hospital at 2 sites 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 13 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 13 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
visual outcomes (time frame: 12 months postoperatively). The study lists 4 primary outcomes in all. 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 13 Mar 2015.