Use of the VisuMax™ Femtosecond Laser

NCT01638390 | Completed Phase 1 Results DMC

• 1 other identifier: VISUMAX-2012-1
• Study Type: interventional
• Target: 357
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Myopia

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  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

  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.

  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.

  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.

  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.

  6 months

Secondary Outcomes (1)

• Safety- Participant Symptoms

  12 months

Study Arms (1)

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.

Device: Treatment with the VisuMax™ Femtosecond Laser

Interventions

Treatment with the VisuMax™ Femtosecond Laser DEVICE

The reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D.

Also known as: VisuMaxTM Femtosecond Laser

Treatment of Myopia

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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;

Sponsors & Collaborators

• Carl Zeiss Meditec, Inc.: lead

Study Sites (5)

Dishler Laser Institute

Greenwood Village, Colorado, 80111, United States

Location

Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

Location

Discover Vision Centers

Leawood, Kansas, 66211, United States

Location

Vance Thompson Vision

Sioux Falls, South Dakota, 57108, United States

Location

Davis Duehr Dean

Madison, Wisconsin, 53717, United States

Location

MeSH Terms

Conditions

Myopia

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Todd Otani, Senior Clinical Research Scientist
• Organization: Carl Zeiss Meditec, Inc.

todd.otani@zeiss.com

925-557-4513

Study Officials

• Jon Dishler, M.D.

  Dishler Laser Institute

  PRINCIPAL INVESTIGATOR

• John Doane, M.D.

  Discover Vision Centers

  PRINCIPAL INVESTIGATOR

• Vance Thompson, M.D.

  Vance Thompson Vision Clinic, Prof., LLC

  PRINCIPAL INVESTIGATOR

• William Culbertson, M.D.

  Bascom Palmer Eye Institute

  PRINCIPAL INVESTIGATOR

• Sonia Yoo, M.D.

  Bascom Palmer Eye Institute

  PRINCIPAL INVESTIGATOR

• John Vukich, M.D.

  Davis Duehr Dean

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2012
• First Posted: July 11, 2012
• Study Start: July 1, 2012
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 2, 2026
• Results First Posted: March 21, 2019

Record last verified: 2026-03

Locations

US (5)