SMILE (Small Incision Lenticule Extraction) in the DoD (Department of Defense)

Status unconfirmed · Not applicable

Conditions studied: Myopia, Astigmatism

In brief

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.

Key facts

Study ID

NCT04072289

Run by

United States Naval Medical Center, San Diego

People needed

180

Starts

2019-05-01

Expected to finish

2024-09-01

Last updated by the study team

2022-04-15

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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
• ≤ -11.50 D in the eye(s) to be treated;
• 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
• ≤ 0.75 D spherical equivalent in both eye(s);
• 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.
• 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;
• Central corneal thickness of at least 500 microns in the both eye(s);
• Willing and able to return for scheduled follow-up examinations;
• Able to provide written informed consent and follow study instructions in English.
• Permission of the Commanding Officer for active duty subjects to receive refractive surgery and participate in the study.

You may not qualify if…

• 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;
• Ophthalmoscopic signs of progressive or unstable myopia or keratoconus (or keratoconus suspect) in either eye;
• Irregular or unstable (distorted/not clear) corneal mires on central keratometry images in either eye;
• History of ocular herpes zoster or herpes simplex keratitis;
• Deep orbits, strong blink, anxiety, pterygium, or any other finding suggesting difficulty in achieving or maintaining suction;
• Difficulty following directions or unable to fixate;
• Previous intraocular or corneal surgery of any kind in the eye to be treated, including any type of surgery for either refractive or therapeutic purposes;
• History of steroid-responsive rise in intraocular pressure, glaucoma, or preoperative IOP > 21 mmHg in either eye;
• History of diabetes, diagnosed autoimmune disease, connective tissue disease or clinically significant atopic syndrome;
• Immunocompromised or requires chronic systemic corticosteroids or other immunosuppressive therapy that may affect wound healing;
• History of known sensitivity to planned study medications;
• Participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation;
• Pregnant or lactating;
• Anyone who has the potential to deploy or relocate during the follow-up period.
• Systemic Medications that may confound the outcome of the study or increase risk to the subject, including but not limited to steroids, antimetabolites, etc.
• Evidence of retinal vascular disease.
• Glaucoma suspects by exam findings or family history.

Where it is running

• Navy Warfighter Refractive Surgery Center — San Diego, California, United States (enrolling)

Full record on ClinicalTrials.gov

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