MyopiaNCT04072289
SMILE (Small Incision Lenticule Extraction) in the DoD (Department of Defense)
A study testing Visumax spherocylindrical treatment in people with Myopia and Astigmatism, run by United States Naval Medical Center, San Diego at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myopia, Astigmatism
- What is being tested?
- Visumax spherocylindrical treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2019to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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);
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Navy Warfighter Refractive Surgery Center
San Diego, California, 92134
Donna Murdoch, Ph.D., 619-524-0771, donna.m.murdoch.ctr@mail.mil
Tyler Miles, O.D., 619-524-0771, tyler.p.miles.mil@mail.mil
About this study
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.
Read the 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.
- Conditions
- Myopia, Astigmatism
- Being tested
- Visumax spherocylindrical treatment
- Keywords
- refractive surgery, small incision lenticule extraction, femtosecond laser, myopia, astigmatism
- Medical subject headings
- Myopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visumax spherocylindrical treatmentDevice
treatment of low cylinder (<0.75D)
| Study group | Role | What they receive |
|---|---|---|
| Low cylinder (treatment) | Experimental | 0.25D and 0.50D cylinder treatments will be measured and treated by the laser. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measured postoperative refractive sphere and cylinder
manifest refraction spherical equivalent and manifest refractive cylinder refraction
Measured: 12 months
Measured distance visual acuity
uncorrected visual acuity of 20/40 or better
Measured: 12 months
Secondary outcomes (10)
Measured difference in manifest refraction between 2 postoperative visits
95% of eyes <1.00D of MRSE change at latter of 2 postop refractions
Measured: 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
mean rate of change of MRSE <0.5D/year (0.04D/mo)
Measured: 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
mean rate of change of MRSE decreases monotonically over time
Measured: 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
95% CI for the mean rate of change includes zero
Measured: 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)
incidence of best spectacled correction worse than 20/40
Measured: 12 months
Measured best corrected visual acuity (method 2)
incidence of loss of >2 lines of best spectacled corrected visual acuity
Measured: 12 months
Measured refractive cylinder
incidence of induced cylinder >2D
Measured: 12 months
Incidence of adverse events
incidence of adverse events
Measured: 12 months
Incidence of patient reported visual phenomena
incidence of patient subjective symptoms
Measured: 12 months
Measured contrast sensitivity
change in contrast sensitivity from preop to postop
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 May 2019
- Primary completionSep 2023 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- comparative cohort trial
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, San Diego
- Sponsor type
- US federal agency
- Collaborators
- Carl Zeiss Meditec, Inc.
- Responsible party
- Principal investigator, John Cason, United States Naval Medical Center, San Diego
- Investigators
- John B. Cason, M.D., Principal investigator, United States Naval Medical Center, San DiegoMatthew C. Caldwell, M.D., Principal investigator, Wilford Hall Air Force HospitalBruce A Rivers, M.D., Principal investigator, Ft. Belvoir Army Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04072289
- Sponsor's protocol ID
- NMCSD-2016.0055
- Status last verified
- Apr 2022
- First submitted
- 11 Mar 2019
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data will be shared with Zeiss Meditech by Data Sharing Agreement and with the FDA
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMILE (Small Incision Lenticule Extraction) in the DoD (Department of Defense)
- ClinicalTrials.gov ID
- NCT04072289
- Acronym / sponsor ID
- NMCSD-2016.0055
- Conditions
- Myopia, Astigmatism
- Keywords
- refractive surgery, small incision lenticule extraction, femtosecond laser, myopia, astigmatism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- United States Naval Medical Center, San DiegoUS federal agency
- Collaborators
- Carl Zeiss Meditec, Inc.
- Study start
- 1 May 2019 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- comparative cohort trial
| Arm | Type | Receives |
|---|---|---|
| Low cylinder (treatment) | Experimental | Device: Visumax spherocylindrical treatment0.25D and 0.50D cylinder treatments will be measured and treated by the laser. |
| 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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (24 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visumax spherocylindrical treatmenttreatment of low cylinder (<0.75D) | Device | Low cylinder (treatment) |
Primary outcome
Measured postoperative refractive sphere and cylinder
Time frame: 12 months
manifest refraction spherical equivalent and manifest refractive cylinder refraction
Measured distance visual acuity
Time frame: 12 months
uncorrected visual acuity of 20/40 or better
10 secondary outcomes
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
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
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
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
Measured best corrected visual acuity (method 1)
Time frame: 12 months
Measured best corrected visual acuity (method 2)
Time frame: 12 months
Measured refractive cylinder
Time frame: 12 months
Incidence of adverse events
Time frame: 12 months
Incidence of patient reported visual phenomena
Time frame: 12 months
Measured contrast sensitivity
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
- Individual participant dataSharing planned: No. Data will be shared with Zeiss Meditech by Data Sharing Agreement and with the FDA
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John B. Cason, M.D. principal investigator
United States Naval Medical Center, San Diego
Matthew C. Caldwell, M.D. principal investigator
Wilford Hall Air Force Hospital
Bruce A Rivers, M.D. principal investigator
Ft. Belvoir Army Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visumax spherocylindrical treatment in people with Myopia and Astigmatism, run by United States Naval Medical Center, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Donna M. Murdoch, PhD (619-524-6737, donna.m.murdoch.ctr@mail.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measured postoperative refractive sphere and cylinder (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2022.