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

NCT04072289 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2022-04-15

No results posted yet for this study

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.

Conditions

  • Myopia
  • Astigmatism

Interventions

DEVICE

Visumax spherocylindrical treatment

treatment of low cylinder (\<0.75D)

Sponsors & Collaborators

  • Carl Zeiss Meditec, Inc.

    collaborator INDUSTRY

  • United States Naval Medical Center, San Diego

    lead FED

Principal Investigators

  • John B. Cason, M.D. · United States Naval Medical Center, San Diego

  • Matthew C. Caldwell, M.D. · Wilford Hall Air Force Hospital

  • Bruce A Rivers, M.D. · Ft. Belvoir Army Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2023-09-30
Completion
2024-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04072289 on ClinicalTrials.gov