- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04072289
SMILE (Small Incision Lenticule Extraction) in the DoD (Department of Defense)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Donna M. Murdoch, PhD
- Phone Number: 619-524-6737
- Email: donna.m.murdoch.ctr@mail.mil
Study Contact Backup
- Name: Myah A Mirzaoff
- Phone Number: 619-524-6482
- Email: myah.a.mirzaoff.ctr@mail.mil
Study Locations
-
-
California
-
San Diego, California, United States, 92134
- Recruiting
- Navy Warfighter Refractive Surgery Center
-
Contact:
- Donna Murdoch, Ph.D.
- Phone Number: 619-524-0771
- Email: donna.m.murdoch.ctr@mail.mil
-
Contact:
- Tyler Miles, O.D.
- Phone Number: 619-524-0771
- Email: tyler.p.miles.mil@mail.mil
-
Principal Investigator:
- John B Cason, M.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Low cylinder (treatment)
0.25D and 0.50D cylinder treatments will be measured and treated by the laser.
|
treatment of low cylinder (<0.75D)
|
NO_INTERVENTION: Low cylinder (no treatment)
0.25D and 0.50D cylinder treatments will be measured but not treated by the laser.
No spherical equivalent will be used.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measured postoperative refractive sphere and cylinder
Time Frame: 12 months
|
manifest refraction spherical equivalent and manifest refractive cylinder refraction
|
12 months
|
Measured distance visual acuity
Time Frame: 12 months
|
uncorrected visual acuity of 20/40 or better
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measured difference in manifest refraction between 2 postoperative visits
Time Frame: latter of 2 postoperative refractions performed at least 3 months apart or at 3 months after surgery when compared with the 1 month interval
|
95% of eyes <1.00D of MRSE change at latter of 2 postop refractions
|
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
Time Frame: latter of 2 postoperative refractions performed at least 3 months apart or at 3 months after surgery when compared with the 1 month interval
|
mean rate of change of MRSE <0.5D/year (0.04D/mo)
|
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
Time Frame: latter of 2 postoperative refractions performed at least 3 months apart or at 3 months after surgery when compared with the 1 month interval
|
mean rate of change of MRSE decreases monotonically over time
|
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
Time Frame: latter of 2 postoperative refractions performed at least 3 months apart or at 3 months after surgery when compared with the 1 month interval
|
95% CI for the mean rate of change includes zero
|
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)
Time Frame: 12 months
|
incidence of best spectacled correction worse than 20/40
|
12 months
|
Measured best corrected visual acuity (method 2)
Time Frame: 12 months
|
incidence of loss of >2 lines of best spectacled corrected visual acuity
|
12 months
|
Measured refractive cylinder
Time Frame: 12 months
|
incidence of induced cylinder >2D
|
12 months
|
Incidence of adverse events
Time Frame: 12 months
|
incidence of adverse events
|
12 months
|
Incidence of patient reported visual phenomena
Time Frame: 12 months
|
incidence of patient subjective symptoms
|
12 months
|
Measured contrast sensitivity
Time Frame: 12 months
|
change in contrast sensitivity from preop to postop
|
12 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: 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
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NMCSD-2016.0055
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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