Optical Quality, Threshold Target Identification, and Military Target Task Performance After Advanced Keratorefractive Surgery
1 other identifier
interventional
224
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2010
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2010
CompletedFirst Posted
Study publicly available on registry
April 1, 2010
CompletedStudy Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedMarch 13, 2015
March 1, 2015
4.5 years
March 31, 2010
March 12, 2015
Conditions
Outcome Measures
Primary Outcomes (4)
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.
12 months postoperatively
objective image quality
as measured by wavefront aberrometry
12 months postoperatively
military task performance
as measured by threshold target identification and night firing range
6 months postoperatively
visual performance
as measured by contrast sensitivity
12 months postoperatively
Study Arms (4)
Wavefront guided (WFG) PRK
ACTIVE COMPARATORWFG LASIK
ACTIVE COMPARATORWavefront optimized (WFO) PRK
ACTIVE COMPARATORWFO LASIK
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889, United States
Fort Belvoir Community Hospital
Fort Belvoir, Virginia, 22060, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kraig S Bower, MD
The Wilmer Eye Institute, Johns Hopkins University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Warfighter Refractive Eye Surgery Program and Research Center at FT Belvoir
Study Record Dates
First Submitted
March 31, 2010
First Posted
April 1, 2010
Study Start
April 1, 2010
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
March 13, 2015
Record last verified: 2015-03