- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01097525
Optical Quality, Threshold Target Identification, and Military Target Task Performance After Advanced Keratorefractive Surgery
March 12, 2015 updated by: LTC Bruce Rivers, Fort Belvoir Community Hospital
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
224
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 53 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / 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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Active Comparator: WFO LASIK
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What is the study measuring?
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
|
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
|
6 months postoperatively
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visual performance
Time Frame: 12 months postoperatively
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as measured by contrast sensitivity
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12 months postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kraig S Bower, MD, The Wilmer Eye Institute, Johns Hopkins University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2010
Primary Completion (Actual)
October 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
March 31, 2010
First Submitted That Met QC Criteria
March 31, 2010
First Posted (Estimate)
April 1, 2010
Study Record Updates
Last Update Posted (Estimate)
March 13, 2015
Last Update Submitted That Met QC Criteria
March 12, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20481
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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