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Refractive Surgery
SMILE Laser Eye Surgery for Near-Sightedness and Astigmatism
N/A
Recruiting
Led By John B. Cason, M.D.
Research Sponsored by United States Naval Medical Center, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Central corneal thickness of at least 500 microns in the both eye(s)
Myopia from ≥ 0 D to ≤ -10.00 D with ≤ -3.00 D cylinder and MRSE ≥ -1.00 D to
Timeline
Screening 3 weeks
Treatment Varies
Follow Up latter of 2 postoperative refractions performed at least 3 months apart or at 3 months after surgery when compared with the 1 month interval
Awards & highlights
Study Summary
This trial will test the VisuMax femtosecond laser for small-incision lenticule extraction (SMILE) to correct myopia with or without astigmatism.
Who is the study for?
This trial is for men and women aged 22 or older, either active duty military or dependents eligible for care. Participants must have stable vision with no significant prescription changes in the past year, not wear contact lenses for weeks before the study, and have a certain level of near-sightedness or astigmatism. They should be able to follow instructions in English and commit to follow-up visits.Check my eligibility
What is being tested?
The SMILE clinical trial tests Visumax spherocylindrical treatment on individuals with near-sightedness or astigmatism. It's a prospective study across multiple centers within the U.S. Department of Defense medical facilities, aiming to correct myopia using this laser procedure.See study design
What are the potential side effects?
While specific side effects are not listed here, similar eye procedures may include discomfort, dry eyes, visual disturbances like glare or halos around lights, potential under-correction or over-correction of vision which might require additional treatments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
Both of my eyes have a corneal thickness of at least 500 microns.
Select...
My nearsightedness is between 0 and -10.00 D, with astigmatism up to -3.00 D.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ latter of 2 postoperative refractions performed at least 3 months apart or at 3 months after surgery when compared with the 1 month interval
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~latter of 2 postoperative refractions performed at least 3 months apart or at 3 months after surgery when compared with the 1 month interval
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Measured distance visual acuity
Measured postoperative refractive sphere and cylinder
Secondary outcome measures
Calculated decreased rate of change in manifest refraction
Calculated rate of change in manifest refraction
Calculated stable rate of change in manifest refraction
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Low cylinder (treatment)Experimental Treatment1 Intervention
0.25D and 0.50D cylinder treatments will be measured and treated by the laser.
Group II: Low cylinder (no treatment)Active Control1 Intervention
0.25D and 0.50D cylinder treatments will be measured but not treated by the laser. No spherical equivalent will be used.
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Who is running the clinical trial?
Carl Zeiss Meditec, Inc.Industry Sponsor
22 Previous Clinical Trials
5,470 Total Patients Enrolled
United States Naval Medical Center, San DiegoLead Sponsor
103 Previous Clinical Trials
22,696 Total Patients Enrolled
John B. Cason, M.D.Principal InvestigatorUnited States Naval Medical Center, San Diego
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 22 or older and eligible for military healthcare.The eye that needs treatment is being aimed for monovision correction.Subjects who are not wearing contact lenses for 4 weeks or 2 weeks prior to the preoperative examination shall not be considered contact lens wearers.I have or had eye problems, including cataracts, in the eye that needs treatment.I might have glaucoma based on tests or family history.You have had a previous eye infection caused by the herpes virus.My eye treatment will not go deeper than 250 microns.I might move or be deployed during the study.You have had a bad reaction to the medications that will be used in the study before.Both of my eyes have a corneal thickness of at least 500 microns.My nearsightedness is between 0 and -10.00 D, with astigmatism up to -3.00 D.I have ongoing severe dry eye problems that treatments haven't fixed.I have had high eye pressure or glaucoma.I have ongoing eye issues, including scars or severe conditions affecting my cornea.I have diabetes, an autoimmune, connective tissue disease, or a significant atopic syndrome.My eyesight is worsening due to myopia or keratoconus.You have certain eye conditions or behaviors that might make it hard to use a suction device during the study.I am not taking any medications that could affect the study results or increase my risk.I am 22 or older and eligible for military healthcare.I am immunocompromised or need medicine that weakens my immune system.I have a disease affecting the blood vessels in my eyes.I have had eye surgery before, including for vision correction or treatment.-11.50 D or less in the eye(s) to be treated.My Commanding Officer has approved my participation in this study.Your glasses or contact lens prescription has not changed by more than half a degree in the past year.
Research Study Groups:
This trial has the following groups:- Group 1: Low cylinder (treatment)
- Group 2: Low cylinder (no treatment)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Near-sightedness Patient Testimony for trial: Trial Name: NCT04072289 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants can join this trial?
"Affirmative. Clinicaltrials.gov's records demonstrate that this project, which was first posted on May 1st 2019, is still seeking participants. 180 patients are required to be recruited from one specific medical centre."
Answered by AI
What is the end goal of this investigation?
"Over the course of 12 months, this trial intends to assess its participants’ distance visual acuity. Secondary objectives include determining best corrected visual acuity (through Method 1), calculating a monotonic decrease in mean rate of spherical equivalent refraction over time and noting any adverse events that may arise."
Answered by AI
Are there any vacancies for participants in this research program?
"As per information hosted on clinicaltrials.gov, this investigation is actively searching for participants. The trial was initially announced in May of 2019 and the most recent update was posted April 14th 2022."
Answered by AI
Who else is applying?
What state do they live in?
Texas
Washington
What site did they apply to?
Navy Warfighter Refractive Surgery Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
My sight is very important to me.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
How long do visits take?
PatientReceived 1 prior treatment
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