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

NCT04072289 | Unknown DMC FDA Device

• 1 other identifier: NMCSD-2016.0055
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia; Astigmatism

Keywords

refractive surgery; small incision lenticule extraction; femtosecond laser; myopia; astigmatism

Outcome Measures

Primary Outcomes (2)

• Measured postoperative refractive sphere and cylinder

  manifest refraction spherical equivalent and manifest refractive cylinder refraction

  12 months

• Measured distance visual acuity

  uncorrected visual acuity of 20/40 or better

  12 months

Secondary Outcomes (10)

• Measured difference in manifest refraction between 2 postoperative visits

  latter of 2 postoperative refractions performed at least 3 months apart or at 3 months after surgery when compared with the 1 month interval

• Calculated rate of change in manifest refraction

  latter of 2 postoperative refractions performed at least 3 months apart or at 3 months after surgery when compared with the 1 month interval

• Calculated decreased rate of change in manifest refraction

  latter of 2 postoperative refractions performed at least 3 months apart or at 3 months after surgery when compared with the 1 month interval

• Calculated stable rate of change in manifest refraction

  latter of 2 postoperative refractions performed at least 3 months apart or at 3 months after surgery when compared with the 1 month interval

• Measured best corrected visual acuity (method 1)

  12 months

Study Arms (2)

Low cylinder (treatment)

EXPERIMENTAL

0.25D and 0.50D cylinder treatments will be measured and treated by the laser.

Device: Visumax spherocylindrical treatment

Low cylinder (no treatment)

NO INTERVENTION

0.25D and 0.50D cylinder treatments will be measured but not treated by the laser. No spherical equivalent will be used.

Interventions

Visumax spherocylindrical treatment DEVICE

treatment of low cylinder (\<0.75D)

Low cylinder (treatment)

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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;

Sponsors & Collaborators

• United States Naval Medical Center, San Diego: lead
• Carl Zeiss Meditec, Inc.: collaborator

Study Sites (1)

Navy Warfighter Refractive Surgery Center

San Diego, California, 92134, United States

RECRUITING

MeSH Terms

Conditions

Myopia; Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• John B. Cason, M.D.

  United States Naval Medical Center, San Diego

  PRINCIPAL INVESTIGATOR

• Matthew C. Caldwell, M.D.

  Wilford Hall Air Force Hospital

  PRINCIPAL INVESTIGATOR

• Bruce A Rivers, M.D.

  Ft. Belvoir Army Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Donna M. Murdoch, PhD

CONTACT

619-524-6737; donna.m.murdoch.ctr@mail.mil

Myah A Mirzaoff

CONTACT

619-524-6482; myah.a.mirzaoff.ctr@mail.mil

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: comparative cohort trial

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: August 28, 2019
• Study Start: May 1, 2019
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2024
• Last Updated: April 15, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)