At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 357 enrolled
Drug / intervention
Treatment with the VisuMax™ Femtosecond Laserdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Use of the VisuMax™ Femtosecond Laser Lenticule Removal Procedure for the Correction of Myopia
In Brief
A Phase 1 clinical trial evaluating Treatment with the VisuMax™ Femtosecond Laser for Myopia. Completed, enrolled 357 participants across 5 sites.
Detailed 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 ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE (Manifest Refractive Spherical Equivalent) ≤ -8.25 D.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyopia
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2012
First PostedJul 2012
Primary CompletionApr 2016
TodayJul 2026
First PostedJul 11, 2012
Enrollment StartJul 1, 2012
Primary CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 14.0 years ago
Interventions
Treatment with the VisuMax™ Femtosecond Laserdevice
The reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D.