Myopia Clinical Trial - Correction of Myopia Wtih or Without Astigmatism

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02430428
Study type	Interventional
Source	Carl Zeiss Meditec, Inc.
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Status	Completed
Phase	N/A
Start date	March 2015
Completion date	October 2017

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms