Correction of Myopia Wtih or Without Astigmatism Using the VisuMax™ Femtosecond Laser

NCT02430428 | Completed

• 1 other identifier: VisuMax-2014-1
• 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 ≤ -10.00 D with ≤ -3.00 D cylinder (myopia with or without astigmatism) and MRSE ≤ -11.50 D.

Conditions

Myopia; Astigmatism

Outcome Measures

Primary Outcomes (6)

• 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

  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

  1 Year

• Preservation of Best-Spectacle Corrected Visual Acuity (BSCVA)

  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

  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

  1 Year

• Incidence of Adverse Events

  Incidence of Adverse Events: The rate of each type of adverse event will be summarized

  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.

  1 Year

Secondary Outcomes (1)

• Patient Symptoms

  1 Year

Study Arms (1)

VisuMax lenticule removal

EXPERIMENTAL

VisuMax femtosecond laser sphere-only or spherocylindrical treatment

Device: Carl Zeiss Meditec VisuMax Femtosecond Laser

Interventions

Carl Zeiss Meditec VisuMax Femtosecond Laser DEVICE

VisuMax femtosecond laser sphere-only or spherocylindrical treatment

VisuMax lenticule removal

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;
• 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;
• 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 \> -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;
• 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;

Sponsors & Collaborators

• Carl Zeiss Meditec, Inc.: lead

Study Sites (5)

Dishler Laser Institute

Greenwood Village, Colorado, 80111, United States

Location

Discover Vision Centers

Leawood, Kansas, 66211, United States

Location

Vance Thompson Vision

Sioux Falls, South Dakota, 57108, United States

Location

Slade and Baker Vision Center

Houston, Texas, 77027, United States

Location

Davis Duehr Dean

Madison, Wisconsin, 53715, United States

Location

MeSH Terms

Conditions

Myopia; Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2015
• First Posted: April 30, 2015
• Study Start: March 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: January 27, 2021

Record last verified: 2021-01

Locations

US (5)