NCT04072289

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: United States Naval Medical Center, San Diego · Federal
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
DEVICE	Visumax spherocylindrical treatment	treatment of low cylinder (\<0.75D)

Timeline

• Start date: 2019-05-01
• Primary completion: 2023-09-01
• Completion: 2024-09-01
• First posted: 2019-08-28
• Last updated: 2022-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study