SMILE (Small Incision Lenticule Extraction) in the DoD (Department of Defense)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Astigmatism
- Myopia
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: comparative cohort trialMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 22 years and 125 years
- Gender
- Both males and females
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 retrea...
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.
Tracking Information
- NCT #
- NCT04072289
- Collaborators
- Carl Zeiss Meditec, Inc.
- 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