SMILE (Small Incision Lenticule Extraction) in the DoD (Department of Defense) (NCT04072289) | Clinical Trial Compass
UnknownNot Applicable
SMILE (Small Incision Lenticule Extraction) in the DoD (Department of Defense)
United States180 participantsStarted 2019-05-01
Plain-language summary
The Use of the VisuMaxTM Femtosecond Laser Small-Incision Lenticule Extraction (SMILE) Procedure for the Correction of Myopia with or without Astigmatism study is a prospective, non-randomized, multicenter clinical study that will be conducted by the Navy Refractive Surgery Center, Naval Medical Center San Diego, CA in collaboration with the U.S. Air Force 59th Medical Wing, Wilford Hall Eye Center, TX, and the U.S. Army Warfighter Refractive Eye Surgery Program and Research Center, Fort Belvoir Community Hospital, VA.
Who can participate
Age range
22 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male and female subjects age 22 years of age and older either active duty or dependents who are eligible for care;
. Myopia from ≥ 0 D to ≤ -10.00 D with ≤ -3.00 D cylinder and MRSE ≥ -1.00 D to
. A stable refraction for the past year, as demonstrated by a change in MRSE of ≤ 0.50 D in the eyes to be treated;
. A difference between cycloplegic and manifest refractions of
. UCVA 2 lines worse than BCVA in the treated eye(s);
. BSCVA at least 20/20 in the treated eye(s);
. Discontinue use of contact lenses for at least 4 weeks (for hard lenses) or 2 weeks (for soft lenses) prior to the preoperative examination, and through entire study. The subject shall not be considered a contact lens wearer if they are not wearing hard contact lenses for 4 weeks or soft contact lenses for 2 weeks.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Measured postoperative refractive sphere and cylinder
Timeframe: 12 months
2
Measured distance visual acuity
Timeframe: 12 months
Trial details
NCT IDNCT04072289
SponsorUnited States Naval Medical Center, San Diego
. All contact lens wearers must demonstrate a stable refraction (within ±0.5 D), as determined by MRSE, on two consecutive examinations at least 7 days apart, in the eye(s) to be treated;
Exclusion criteria
. Manifest cylinder of more than -3.00 D;
. Estimated treatment depth is less than 250 microns from the corneal endothelium;
. Eye to be treated is targeted for monovision;
. Keratometry readings via Sim-K values less than 40.00 D;
. Abnormal corneal topographic findings, e.g. keratoconus, pellucid marginal degeneration in either eye;
. History of or current anterior segment pathology, including cataracts in the eye to be treated;
. Clinically significant dry eye syndrome unresolved by treatment in either eye;
. Residual, recurrent, active ocular or uncontrolled eyelid disease, corneal scars or other corneal abnormality such as recurrent corneal erosion or severe basement membrane disease in the either eye;