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 range22 Years
SexALL
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Inclusion criteria
ā. Male and female subjects age 22 years of age and older either active duty or dependents who are eligible for care;
ā. Myopia from ā„ 0 D to ā¤ -10.00 D with ā¤ -3.00 D cylinder and MRSE ā„ -1.00 D to
ā. A stable refraction for the past year, as demonstrated by a change in MRSE of ā¤ 0.50 D in the eyes to be treated;
ā. A difference between cycloplegic and manifest refractions of
ā. UCVA 2 lines worse than BCVA in the treated eye(s);
ā. BSCVA at least 20/20 in the treated eye(s);
ā. 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.
ā. All contact lens wearers must demonstrate a stable refraction (within Ā±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
ā. Manifest cylinder of more than -3.00 D;
ā. Estimated treatment depth is less than 250 microns from the corneal endothelium;
ā. Eye to be treated is targeted for monovision;
ā
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
. Keratometry readings via Sim-K values less than 40.00 D;
ā. Abnormal corneal topographic findings, e.g. keratoconus, pellucid marginal degeneration in either eye;
ā. History of or current anterior segment pathology, including cataracts in the eye to be treated;
ā. Clinically significant dry eye syndrome unresolved by treatment in either eye;
ā. 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;