Status:
UNKNOWN
SMILE (Small Incision Lenticule Extraction) in the DoD (Department of Defense)
Lead Sponsor:
United States Naval Medical Center, San Diego
Collaborating Sponsors:
Carl Zeiss Meditec, Inc.
Conditions:
Myopia
Astigmatism
Eligibility:
All Genders
22+ years
Phase:
NA
Brief 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, multic...
Detailed Description
Prospective, multicenter, open-label, non-randomized clinical trial with bilateral commercial treatment for FDA approved indications and unilateral treatments for investigational refractive errors. Da...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT04072289
Start Date
May 1 2019
End Date
September 1 2024
Last Update
April 15 2022
Active Locations (1)
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1
Navy Warfighter Refractive Surgery Center
San Diego, California, United States, 92134