Optical Quality, Threshold Target Identification, and Military Target Task Performance After Advanced Keratorefractive Surgery
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Maryland
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Bethesda, Maryland, United States, 20889
- Walter Reed National Military Medical Center
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Virginia
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Fort Belvoir, Virginia, United States, 22060
- Fort Belvoir Community Hospital
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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).
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Active Comparator: Wavefront guided (WFG) PRK
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|
|
Active Comparator: WFG LASIK
|
|
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Active Comparator: Wavefront optimized (WFO) PRK
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|
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Active Comparator: WFO LASIK
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
visual outcomes
Time Frame: 12 months postoperatively
|
Visual outcomes will be measured in terms of:
|
12 months postoperatively
|
|
objective image quality
Time Frame: 12 months postoperatively
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as measured by wavefront aberrometry
|
12 months postoperatively
|
|
military task performance
Time Frame: 6 months postoperatively
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as measured by threshold target identification and night firing range
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6 months postoperatively
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|
visual performance
Time Frame: 12 months postoperatively
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as measured by contrast sensitivity
|
12 months postoperatively
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Kraig S Bower, MD, The Wilmer Eye Institute, Johns Hopkins University
Study record dates
Study Major Dates
Study Start
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimate)
First Posted
Study Record Updates
Last Update Posted (Estimate)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 20481
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