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NCT01638390 · ClinicalTrials.gov registry record · Phase 1
Use of the VisuMax™ Femtosecond Laser
A Phase 1 study, sponsored by Carl Zeiss Meditec.
- Completed
- Registry status
- Phase 1
- Development phase
- 357
- Enrollment target
NCT01638390: Completed Phase 1 study, sponsored by Carl Zeiss Meditec.
NCT01638390 is a Phase 1 study that has completed, run by Carl Zeiss Meditec. The registered enrollment target is 357 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (495% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01638390, a Phase 1 study, has completed, sponsored by Carl Zeiss Meditec.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 357 participants
- Enrollment target
Study 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.
Primary Outcome
Number of participants with a decrease in manifest refraction spherical equivalent (MRSE) to within ± 1.00 D and ± 0.50 D of the intended refractive outcome at the point at which stability is first reached. The MRSE is the amount of prescription needed to obtain your best corrected vision as compared to your preoperative best corrected vision. A minimum of 75% of eyes should have an achieved refraction within ± 1.00 D of the intended outcome, and at least 50% of eyes should be within ± 0.50 D of
Interventions
- DEVICE Treatment with the VisuMax™ Femtosecond Laser
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 357 participants |
| Start Date | 2012-07 |
| Est. Completion | 2016-04 |
| Phase | Phase 1 |
What the finished NCT01638390 record still lists
NCT01638390 is an interventional study that assigns participants to a tested intervention. The registered 357 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (495% higher).
The record links to 0 conditions, and to 1 intervention - of which Treatment with the VisuMax™ Femtosecond Laser is the first listed.
NCT01638390 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01638390 about?
NCT01638390 is a clinical study titled "Use of the VisuMax™ Femtosecond Laser". 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 Equ...
What is the current status of trial NCT01638390?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 357 participants. The study started on 2012-07. Estimated completion is 2016-04.
What interventions are being tested in trial NCT01638390?
The interventions under investigation include: Treatment with the VisuMax™ Femtosecond Laser (DEVICE).
Who is sponsoring clinical trial NCT01638390?
This trial is sponsored by Carl Zeiss Meditec, which has 18 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01638390's enrollment target sits among peer trials
357 95th of 2000 higher than 1,906 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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