NCT02430428

Correction of Myopia Wtih or Without Astigmatism Using the VisuMax™ Femtosecond Laser

Use of the VisuMax™ Femtosecond Laser Lenticule Removal Procedure for the Correction of Myopia Wtih or Without Astigmatism

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 357 (actual)
• Sponsor: Carl Zeiss Meditec, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

Summary

The objective of this clinical trial is to evaluate the safety and effectiveness of the Carl Zeiss Meditec VisuMax™ Femtosecond Laser lenticule removal procedure for the reduction or elimination of myopia from ≥ -1.00 D to ≤ -10.00 D with ≤ -3.00 D cylinder (myopia with or without astigmatism) and MRSE ≤ -11.50 D.

Detailed description

This is a prospective multi-center clinical trial in which a maximum of 360 eyes of 360 consecutive subjects will be enrolled and treated with the VisuMax™ Femtosecond Laser. The study will be conducted at up to 8 clinical sites. Subjects will be screened for eligibility, and informed consent will be obtained from those who meet screening criteria and are interested in participating in the study. Eligible subjects will be examined preoperatively to obtain a medical history and to establish a baseline ocular condition. Baseline and postoperative measurements will include manifest refraction, cycloplegic refraction, distance visual acuity (best corrected and uncorrected), slit-lamp examination, fundus examination, corneal topography, central corneal pachymetry, mesopic pupil measurement, wavefront analysis, mesopic contrast sensitivity, and intraocular pressure (IOP). Only eyes with astigmatism ≥ -0.75 D to ≤ -3.00 D targeted for the full distance manifest spherocylindrical refraction, or eye(s) with astigmatism \< -0.75 D targeted for the full distance manifest sphere-only refraction, will be enrolled into the study. Subjects must have astigmatism ≤ -3.00 D in the eye to be treated. Eyes with astigmatism ≥ -0.75 D to ≤ -3.00 D will receive a spherocylindrical treatment. Eyes with astigmatism \< -0.75 D will receive a sphere-only treatment. Operative eyes with astigmatism ≥ -0.75 D to ≤ -3.00 D must be targeted for the full distance manifest spherocylindrical refraction. Operative eye(s) with astigmatism \< -0.75 D must be targeted for the full distance manifest sphere-only refraction. Monovision treatments and retreatments of the study eye will not be allowed during the course of the study. Bilateral investigational treatments will not be allowed during the study. Safety and effectiveness criteria from the American National Standard for Ophthalmics (ANSI Z80.11-2012) - Laser Systems for Corneal Reshaping will be utilized in the evaluation of the VisuMax Femtosecond Laser.

Conditions

• Myopia
• Astigmatism

Interventions

Type	Name	Description
DEVICE	Carl Zeiss Meditec VisuMax Femtosecond Laser	VisuMax femtosecond laser sphere-only or spherocylindrical treatment

Timeline

• Start date: 2015-03-01
• Primary completion: 2017-10-01
• Completion: 2017-10-01
• First posted: 2015-04-30
• Last updated: 2021-01-27

Locations

5 sites across 1 country: United States