Clinical trial NCT04072289: SMILE (Small Incision Lenticule Extraction) in the DoD (Department of Defense)
Official title: SMILE (Small Incision Lenticule Extraction) in the DoD (Department of Defense)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myopia
Astigmatism
Keywords: refractive surgery
small incision lenticule extraction
femtosecond laser
myopia
astigmatism
Lead sponsor: United States Naval Medical Center, San Diego
Sponsor class: FED
Collaborators: name: Carl Zeiss Meditec, Inc.
First posted: 2019-08-28
Enrollment: 180
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: comparative cohort trial
Primary purpose: TREATMENT

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, 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.

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. Data from each treated eye of subjects will be treated independently. Monovision treatments and retreatments of the study eye will not be allowed during the course of the study. Successful bilateral treatment is required for performance based testing and patient reported outcome testing. Subjects will be randomized into the 0.25 and 0.50 sphere only and spherical cylinder bins using a sequential alternating randomization with an equal number assigned to both bins. Other subjects will be assigned to the bins they qualify for as they are enrolled into the study. Appointments are given to patients requesting refractive surgery randomly.

Three military sites in the U.S.A.: 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.

Eligibility criteria: Inclusion Criteria:

1. Male and female subjects age 22 years of age and older either active duty or dependents who are eligible for care;
2. 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;
3. A stable refraction for the past year, as demonstrated by a change in MRSE of ≤ 0.50 D in the eyes to be treated;
4. A difference between cycloplegic and manifest refractions of

   ≤ 0.75 D spherical equivalent in both eye(s);
5. UCVA 2 lines worse than BCVA in the treated eye(s);
6. BSCVA at least 20/20 in the treated eye(s);
7. 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.
8. 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;
9. Central corneal thickness of at least 500 microns in the both eye(s);
10. Willing and able to return for scheduled follow-up examinations;
11. Able to provide written informed consent and follow study instructions in English.
12. Permission of the Commanding Officer for active duty subjects to receive refractive surgery and participate in the study.

Exclusion Criteria:

1. Manifest cylinder of more than -3.00 D;
2. Estimated treatment depth is less than 250 microns from the corneal endothelium;
3. Eye to be treated is targeted for monovision;
4. Keratometry readings via Sim-K values less than 40.00 D;
5. Abnormal corneal topographic findings, e.g. keratoconus, pellucid marginal degeneration in either eye;
6. History of or current anterior segment pathology, including cataracts in the eye to be treated;
7. Clinically significant dry eye syndrome unresolved by treatment in either eye;
8. 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;
9. Ophthalmoscopic signs of progressive or unstable myopia or keratoconus (or keratoconus suspect) in either eye;
10. Irregular or unstable (distorted/not clear) corneal mires on central keratometry images in either eye;
11. History of ocular herpes zoster or herpes simplex keratitis;
12. Deep orbits, strong blink, anxiety, pterygium, or any other finding suggesting difficulty in achieving or maintaining suction;
13. Difficulty following directions or unable to fixate;
14. 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;
15. History of steroid-responsive rise in intraocular pressure, glaucoma, or preoperative IOP \> 21 mmHg in either eye;
16. History of diabetes, diagnosed autoimmune disease, connective tissue disease or clinically significant atopic syndrome;
17. Immunocompromised or requires chronic systemic corticosteroids or other immunosuppressive therapy that may affect wound healing;
18. History of known sensitivity to planned study medications;
19. Participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation;
20. Pregnant or lactating;
21. Anyone who has the potential to deploy or relocate during the follow-up period.
22. Systemic Medications that may confound the outcome of the study or increase risk to the subject, including but not limited to steroids, antimetabolites, etc.
23. Evidence of retinal vascular disease.
24. Glaucoma suspects by exam findings or family history.

Primary outcomes:
measure: Measured postoperative refractive sphere and cylinder
timeFrame: 12 months
measure: Measured distance visual acuity
timeFrame: 12 months
Secondary outcomes:
measure: Measured difference in manifest refraction between 2 postoperative visits
timeFrame: latter of 2 postoperative refractions performed at least 3 months apart or at 3 months after surgery when compared with the 1 month interval
measure: Calculated rate of change in manifest refraction
timeFrame: latter of 2 postoperative refractions performed at least 3 months apart or at 3 months after surgery when compared with the 1 month interval
measure: Calculated decreased rate of change in manifest refraction
timeFrame: latter of 2 postoperative refractions performed at least 3 months apart or at 3 months after surgery when compared with the 1 month interval
measure: Calculated stable rate of change in manifest refraction
timeFrame: latter of 2 postoperative refractions performed at least 3 months apart or at 3 months after surgery when compared with the 1 month interval
measure: Measured best corrected visual acuity (method 1)
timeFrame: 12 months
measure: Measured best corrected visual acuity (method 2)
timeFrame: 12 months
measure: Measured refractive cylinder
timeFrame: 12 months
measure: Incidence of adverse events
timeFrame: 12 months
measure: Incidence of patient reported visual phenomena
timeFrame: 12 months
measure: Measured contrast sensitivity
timeFrame: 12 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Navy Warfighter Refractive Surgery Center
state: California
Study officials:
affiliation: United States Naval Medical Center, San Diego
name: John B. Cason, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Wilford Hall Air Force Hospital
name: Matthew C. Caldwell, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ft. Belvoir Army Hospital
name: Bruce A Rivers, M.D.
role: PRINCIPAL_INVESTIGATOR
References: