MyopiaNCT02430428
Correction of Myopia Wtih or Without Astigmatism Using the VisuMax™ Femtosecond Laser
A study testing Carl Zeiss Meditec VisuMax Femtosecond Laser in people with Myopia and Astigmatism, run by Carl Zeiss Meditec, Inc. at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myopia, Astigmatism
- What is being tested?
- Carl Zeiss Meditec 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
- Mar 2015to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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;
- Myopia from ≥ -1.00 D to ≤ -10.00 D with ≤ -3.00 D cylinder and MRSE ≤ -11.50 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 > -3.00 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;
- Keratometry readings via Sim-K values less than 40.00 D;
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- Abnormal corneal topographic findings, e.g. keratoconus, pellucid marginal degeneration in either eye;
- 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 immunosuppresive 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.
5 sites in 1 country
United States5 sites
Dishler Laser Institute
Greenwood Village, Colorado, 80111
Slade and Baker Vision Center
Houston, Texas, 77027
Discover Vision Centers
Leawood, Kansas, 66211
Davis Duehr Dean
Madison, Wisconsin, 53715
Vance Thompson Vision
Sioux Falls, South Dakota, 57108
About this study
Official title: Use of the VisuMax™ Femtosecond Laser Lenticule Removal Procedure for the Correction of Myopia Wtih or Without Astigmatism
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.
Read the detailed 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.
- Conditions
- Myopia, Astigmatism
- Being tested
- Carl Zeiss Meditec VisuMax Femtosecond Laser
- Medical subject headings
- Myopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carl Zeiss Meditec VisuMax Femtosecond LaserDevice
VisuMax femtosecond laser sphere-only or spherocylindrical treatment
| Study group | Role | What they receive |
|---|---|---|
| VisuMax lenticule removal | Experimental | VisuMax femtosecond laser sphere-only or spherocylindrical treatment Receives: Device: Carl Zeiss Meditec VisuMax Femtosecond Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with MRSE within ± 1.00 D and ± 0.50 D
Predictability: 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
Measured: 1 Year
Improvement in UCVA following treatment
The uncorrected visual acuity of 20/40 or better for eyes targeted for emmetropia at the postoperative interval at which stability has been established
Measured: 1 Year
Preservation of Best-Spectacle Corrected Visual Acuity (BSCVA)
Preservation of Best-Spectacle Corrected Visual Acuity (BSCVA):
- In eyes with preoperative BSCVA 20/20 or better, the percentage of eyes with BSCVA worse than 20/40 at the postoperative interval at which stability has been established
- The percentage of eyes with BCVA loss ≥ 2 lines
Measured: 1 Year
Number of subjects with induced MRCyl > 2.00 D
Induced manifest refractive astigmatism: The percentage of eyes treated for spherical myopia only with induced manifest refractive cylinder of > 2.00 D at the postoperative interval at which stability has been established
Measured: 1 Year
Incidence of Adverse Events
Incidence of Adverse Events: The rate of each type of adverse event will be summarized
Measured: 1 Year
Change in Contrast Sensitivity
Contrast Sensitivity: Mean of "within-eye" loss of contrast sensitivity from baseline to 12 months will be provided with the 1-sided 95% confidence interval for each spatial frequency. Percentage of eyes showing ≥ 0.3 log units loss at two or more spatial frequencies at the last available postoperative visit will be calculated.
Measured: 1 Year
Secondary outcomes (1)
Patient Symptoms
Patient Symptoms: Will be considered as a secondary safety variable and will be evaluated via a subject questionnaire.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 357 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carl Zeiss Meditec, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02430428
- Sponsor's protocol ID
- VisuMax-2014-1
- Status last verified
- Jan 2021
- First submitted
- 23 Apr 2015
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. 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 Wtih or Without Astigmatism
- ClinicalTrials.gov ID
- NCT02430428
- Acronym / sponsor ID
- VisuMax-2014-1
- Conditions
- Myopia, Astigmatism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 357 participants (actual)
- Lead sponsor
- Carl Zeiss Meditec, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 30 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VisuMax lenticule removal | Experimental | Device: Carl Zeiss Meditec VisuMax Femtosecond LaserVisuMax femtosecond laser sphere-only or spherocylindrical treatment |
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;
- Myopia from ≥ -1.00 D to ≤ -10.00 D with ≤ -3.00 D cylinder and MRSE ≤ -11.50 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 (22 listed)
- Mesopic pupil diameter >8.0 mm;
- Cylinder > -3.00 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 |
|---|---|---|
| Carl Zeiss Meditec VisuMax Femtosecond LaserVisuMax femtosecond laser sphere-only or spherocylindrical treatment | Device | VisuMax lenticule removal |
Primary outcome
Number of subjects with MRSE within ± 1.00 D and ± 0.50 D
Time frame: 1 Year
Predictability: 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
Improvement in UCVA following treatment
Time frame: 1 Year
The uncorrected visual acuity of 20/40 or better for eyes targeted for emmetropia at the postoperative interval at which stability has been established
Preservation of Best-Spectacle Corrected Visual Acuity (BSCVA)
Time frame: 1 Year
Preservation of Best-Spectacle Corrected Visual Acuity (BSCVA): 1. In eyes with preoperative BSCVA 20/20 or better, the percentage of eyes with BSCVA worse than 20/40 at the postoperative interval at which stability has been established 2. The percentage of eyes with BCVA loss ≥ 2 lines
Number of subjects with induced MRCyl > 2.00 D
Time frame: 1 Year
Induced manifest refractive astigmatism: The percentage of eyes treated for spherical myopia only with induced manifest refractive cylinder of > 2.00 D at the postoperative interval at which stability has been established
Incidence of Adverse Events
Time frame: 1 Year
Incidence of Adverse Events: The rate of each type of adverse event will be summarized
Change in Contrast Sensitivity
Time frame: 1 Year
Contrast Sensitivity: Mean of "within-eye" loss of contrast sensitivity from baseline to 12 months will be provided with the 1-sided 95% confidence interval for each spatial frequency. Percentage of eyes showing ≥ 0.3 log units loss at two or more spatial frequencies at the last available postoperative visit will be calculated.
1 secondary outcome
Patient Symptoms
Time frame: 1 Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carl Zeiss Meditec VisuMax Femtosecond Laser in people with Myopia and Astigmatism, 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 22 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 27 Jan 2021. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of subjects with MRSE within ± 1.00 D and ± 0.50 D (time frame: 1 Year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2021; AzTrials last refreshed its copy on 1 Nov 2026.