Use of the VisuMax™ Femtosecond Laser (NCT01638390) | Clinical Trial Compass
CompletedPhase 1
Use of the VisuMax™ Femtosecond Laser
United States357 participantsStarted 2012-07
Plain-language 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.
Who can participate
Age range
22 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male and female subjects age 22 years of age and older;
* Spherical myopia from ≥ -1.00 D to ≤ -8.00 D, with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D in the eye to be treated;
* A stable refraction for the past year, as demonstrated by a change in MRSE of ≤ 0.50 D in the eye to be treated;
* A difference between cycloplegic and manifest refractions of \< 0.75 D spherical equivalent in the eye to be treated;
* UCVA worse than 20/40 in the eye to be treated;
* BSCVA at least 20/20 in the eye to be treated;
* Discontinue use of contact lenses for at least 2 weeks (for hard lenses) or 3 days (for soft lenses) prior to the preoperative examination, and through the day of surgery;
* All contact lens wearers must demonstrate a stable refraction (within ±0.5 D), as determined by MRSE, on two consecutive examinations at least 1 week apart, in the eye to be treated;
* Central corneal thickness of at least 500 microns in the eye to be treated;
* Willing and able to return for scheduled follow-up examinations;
* Able to provide written informed consent and follow study instructions in English.
Exclusion Criteria:
* Mesopic pupil diameter \> 8.0 mm;
* Cylinder \> -0.50 D;
* Treatment depth is less than 250 microns from the corneal endothelium;
* Eye to be treated is targeted for monovision;
* Fellow eye has BSCVA worse than 20/40;
* Abnormal corneal topographic findings, e.g. keratoconus, pellucid marginal degeneration in either eye;
* History of or current anterior …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This was a Phase 1 trial for the VisuMax femtosecond laser for myopia — since Phase 1 studies are mainly early-stage safety and feasibility work, what do we actually know so far about whether this procedure is safe and effective compared to more established laser vision correction options?
2One of the things this trial tracked was whether participants lost any of their best corrected vision after the procedure — given that this is still an investigational device study, how likely is it that my prescription correction or overall vision quality could be worse after treatment than it is now with glasses or contacts?
3The trial measured whether participants developed new or worsened astigmatism after the laser treatment — is that a meaningful risk I should weigh before considering this kind of procedure, and how would that be managed if it happened?
4The study also looked at contrast sensitivity, which affects how well you see in low-light situations like driving at night — based on what's been reported from this trial, is there any concern about that kind of vision quality change with this laser?
5Since this trial is now completed, has the data led to any FDA clearance or updated guidance for this device, and would a more established procedure like LASIK or SMILE be a safer or better-studied option for someone in my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Effectiveness- Predictability of Participant Refractive Outcomes
Timeframe: 12 months
2
Effectiveness- Number of Participants With an Improvement in UCVA Following Treatment
Timeframe: 12 month
3
Stability Criteria- Number of Participants With a Change Between Visits Within 1.00 Diopter (D)
Timeframe: 6 months
4
Safety- Number of Participants With a Preservation of Best-Spectacle Corrected Visual Acuity (BSCVA)
Timeframe: 12 months
5
Safety- Number of Participants With Induced Manifest Refractive Astigmatism
Timeframe: 12 months
6
Safety- Number of Participants With Adverse Events