MyopiaPhase 1NCT01638390

Use of the VisuMax™ Femtosecond Laser

A Phase 1 study testing Treatment with the VisuMax™ Femtosecond Laser in people with Myopia, run by Carl Zeiss Meditec, Inc. at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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 ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE (Manifest Refractive Spherical Equivalent) ≤ -8.25 D. Read more about this study

Who is it for?: Ages 22 years and olderHealthy volunteers can take part
Conditions the study is for: Myopia
What is being tested?: Treatment with the VisuMax™ Femtosecond Laser
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 357 participants
Where: 5 sitesUnited States
Study dates: Jul 2012to Apr 2016
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 22 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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;

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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.

Who cannot join

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;

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History of or current anterior segment pathology, including cataracts in the eye to be treated;
Clinically significant dry eye syndrome unresolved by treatment in either eye;
Residual, recurrent, active ocular or uncontrolled eyelid disease, corneal scars or other corneal abnormality such as recurrent corneal erosion or severe basement membrane disease in the eye to be treated;
Ophthalmoscopic signs of progressive or unstable myopia or keratoconus (or keratoconus suspect) in either eye;
Irregular or unstable (distorted/not clear) corneal mires on central keratometry images in either eye;
History of ocular herpes zoster or herpes simplex keratitis;
Deep orbits, strong blink, anxiety, pterygium, or any other finding suggesting difficulty in achieving or maintaining suction;
Difficulty following directions or unable to fixate;
Previous intraocular or corneal surgery of any kind in the eye to be treated, including any type of surgery for either refractive or therapeutic purposes;
History of steroid-responsive rise in intraocular pressure, glaucoma, or preoperative IOP > 21 mmHg in either eye;
History of diabetes, diagnosed autoimmune disease, connective tissue disease or clinically significant atopic syndrome;
Immunocompromised or requires chronic systemic corticosteroids or other immunosuppressive therapy that may affect wound healing;
History of known sensitivity to planned study medications;
Participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation;
Pregnant, lactating, or of child-bearing potential and not practicing a medically approved method of birth control.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Dishler Laser Institute
Greenwood Village, Colorado, 80111
Discover Vision Centers
Leawood, Kansas, 66211
Davis Duehr Dean
Madison, Wisconsin, 53717
Bascom Palmer Eye Institute
Miami, Florida, 33136
Vance Thompson Vision
Sioux Falls, South Dakota, 57108

Other trials in United States

About this study

Official title: Use of the VisuMax™ Femtosecond Laser Lenticule Removal Procedure for the Correction of Myopia

Read the detailed description

This is a prospective multi-center clinical trial in which a total of 360 eyes of consecutive subjects will be enrolled, treated with the VisuMax™ Femtosecond Laser, and followed for a 12-month period. The study will be conducted at up to 8 clinical sites.

Enrollment will be phased such that 100 eyes will be initially enrolled and followed. When 50 of the initial eyes have reached the 3-month follow-up exam, an interim clinical study report will be submitted to FDA along with a request to continue enrollment up to 360 eyes.

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).

Conditions: Myopia
Being tested: Treatment with the VisuMax™ Femtosecond Laser
Medical subject headings: Myopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Treatment with the VisuMax™ Femtosecond LaserDevice
Also called VisuMaxTM Femtosecond Laser
The reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D.

Study groups in NCT01638390
Study group	Role	What they receive
Treatment of Myopia	Other	The reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D. Receives: Device: Treatment with the VisuMax™ Femtosecond Laser

What is being measured

The primary outcome is the main question the study is designed to answer.

Effectiveness- Predictability of Participant Refractive Outcomes
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 the intended outcome.
Measured: 12 months
Effectiveness- Number of Participants With an Improvement in UCVA Following Treatment
Number of participants with uncorrected visual acuity (UCVA) of 20/40 or better at the point of stability. .This is vision without any form of prescription. A target of 85% of participants is required.
Measured: 12 month
Stability Criteria- Number of Participants With a Change Between Visits Within 1.00 Diopter (D)
Number of participants with a change in postoperative refraction within 1.00 D between the 3 and 6 month visits. Stability was identified at the 6 month visit for the study.
Measured: 6 months
Safety- Number of Participants With a Preservation of Best-Spectacle Corrected Visual Acuity (BSCVA)
1. Number of participants with worse than 20/40 visual acuity with a preoperative BSCVA (Best Spectacle Corrected Visual Acuity) 20/20 or better. Target is less than 1% of study participants.
2. Less than 5% of participants with BCVA loss ≥ 2 lines
Measured: 12 months
Safety- Number of Participants With Induced Manifest Refractive Astigmatism
Number of participants with an increase of astigmatism of greater than 2.00 D cylinder from the preoperative values. Target is less than 5% of participants.
Measured: 12 months
Safety- Number of Participants With Adverse Events
Number of participants for each type of adverse event. Target of less than 1% of participants for each type of adverse event.
Measured: 12 months
Safety- Contrast Sensitivity of Participants
Number of participants who increased, remained the same, and decreased in contrast sensitivity. There are 4 different frequencies (1.5, 3.0, 6.0, and 12.0) which will be tested and are more difficult to detect as the frequency number increases.
Measured: 12 months
Stability Criteria- Number of Participants With a Change Between Visits Within 0.50 Diopter (D)
Number of participants with a change in postoperative refraction within 0.50 D between the 3 and 6 month visits. Stability was identified at the 6 month visit for the study.
Measured: 6 months

Secondary outcomes (1)

Safety- Participant Symptoms
A standardized quality of vision (QoV) questionnaire was used in the study. A score is generated and was used to compare the results from baseline to the 12 month visit. Number of participants who improved, stayed the same, or worsened with regards to the frequency, severity, and bothersomeness of symptoms are reported.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2012Apr 2016

First posted11 Jul 2012 (estimated)
Study startJul 2012
Primary completionApr 2016
Study completionApr 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for MyopiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 357 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01638390
Sponsor's protocol ID: VISUMAX-2012-1
Status last verified: Mar 2026
First submitted: 2 Jul 2012
Last updated: 2 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
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Clinical Performance and Outcomes After Toric Lens Transition
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Active, not recruiting
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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Use of the VisuMax™ Femtosecond Laser Lenticule Removal Procedure for the Correction of Myopia
ClinicalTrials.gov ID: NCT01638390
Acronym / sponsor ID: VISUMAX-2012-1
Conditions: Myopia
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 357 participants (actual)
Lead sponsor: Carl Zeiss Meditec, Inc.Industry (pharma, biotech, devices)
Study start: Jul 2012
Primary completion: Apr 2016 (actual)
Study completion: Apr 2016 (actual)
First posted: 11 Jul 2012 (estimated)
Results: Posted 21 Mar 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment of Myopia	Other	Device: Treatment with the VisuMax™ Femtosecond LaserThe reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D.

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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;

Key exclusion criteria (21 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Treatment with the VisuMax™ Femtosecond LaserAlso: VisuMaxTM Femtosecond LaserThe reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D.	Device	Treatment of Myopia

Primary outcome

Effectiveness- Predictability of Participant Refractive Outcomes
Time frame: 12 months
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 the intended outcome.
Effectiveness- Number of Participants With an Improvement in UCVA Following Treatment
Time frame: 12 month
Number of participants with uncorrected visual acuity (UCVA) of 20/40 or better at the point of stability. .This is vision without any form of prescription. A target of 85% of participants is required.
Stability Criteria- Number of Participants With a Change Between Visits Within 1.00 Diopter (D)
Time frame: 6 months
Number of participants with a change in postoperative refraction within 1.00 D between the 3 and 6 month visits. Stability was identified at the 6 month visit for the study.
Safety- Number of Participants With a Preservation of Best-Spectacle Corrected Visual Acuity (BSCVA)
Time frame: 12 months
1. Number of participants with worse than 20/40 visual acuity with a preoperative BSCVA (Best Spectacle Corrected Visual Acuity) 20/20 or better. Target is less than 1% of study participants. 2. Less than 5% of participants with BCVA loss ≥ 2 lines
Safety- Number of Participants With Induced Manifest Refractive Astigmatism
Time frame: 12 months
Number of participants with an increase of astigmatism of greater than 2.00 D cylinder from the preoperative values. Target is less than 5% of participants.
Safety- Number of Participants With Adverse Events
Time frame: 12 months
Number of participants for each type of adverse event. Target of less than 1% of participants for each type of adverse event.
Safety- Contrast Sensitivity of Participants
Time frame: 12 months
Number of participants who increased, remained the same, and decreased in contrast sensitivity. There are 4 different frequencies (1.5, 3.0, 6.0, and 12.0) which will be tested and are more difficult to detect as the frequency number increases.
Stability Criteria- Number of Participants With a Change Between Visits Within 0.50 Diopter (D)
Time frame: 6 months
Number of participants with a change in postoperative refraction within 0.50 D between the 3 and 6 month visits. Stability was identified at the 6 month visit for the study.

1 secondary outcome

Safety- Participant Symptoms
Time frame: 12 months

Results and safety

Results posted to the registry on 21 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment of Myopia	357	336

Primary outcome: Effectiveness- Predictability of Participant Refractive Outcomes

Time frame: 12 months. Count of participants. Unit: Participants

Measure	Treatment of Myopia n = 310
MRSE, Attempted vs. Achieved, ±0.50 D	291
MRSE, Attempted vs. Achieved, ±1.00 D	306

Population analysed: The number reflected at the 12 month visit is the effectiveness population.

Primary outcome: Effectiveness- Number of Participants With an Improvement in UCVA Following Treatment

Time frame: 12 month. Count of participants. Unit: Participants

Measure	Treatment of Myopia n = 310
Value	309

Population analysed: The number reflected at the 12 month visit is the effectiveness population.

Primary outcome: Stability Criteria- Number of Participants With a Change Between Visits Within 1.00 Diopter (D)

Time frame: 6 months. Count of participants. Unit: Participants

Measure	Treatment of Myopia n = 327
Value	327

Primary outcome: Safety- Number of Participants With a Preservation of Best-Spectacle Corrected Visual Acuity (BSCVA)

Time frame: 12 months. Count of participants. Unit: Participants

Measure	Treatment of Myopia n = 336
BSCVA worse than 20/40 if 20/20 or better preopera	0
Loss of ≥ 2 lines BSCVA	0

1 secondary outcome is reported in the full results.

Adverse events

Time frame: approximately 2 years, 11 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment of Myopia	0 of 336 (0%)	14 of 336 (4.2%)	0 of 336

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Myopia

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jon Dishler, M.D. principal investigator

Dishler Laser Institute

John Doane, M.D. principal investigator

Discover Vision Centers

Vance Thompson, M.D. principal investigator

Vance Thompson Vision Clinic, Prof., LLC

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Treatment with the VisuMax™ Femtosecond Laser in people with Myopia, run by Carl Zeiss Meditec, Inc. at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effectiveness- Predictability of Participant Refractive Outcomes (time frame: 12 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01638390.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.