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

NCT ID: NCT02430428

Last Updated: 2021-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 357 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2017-10-31

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VisuMax lenticule removal

VisuMax femtosecond laser sphere-only or spherocylindrical treatment

Group Type: EXPERIMENTAL

Carl Zeiss Meditec VisuMax Femtosecond Laser

Intervention Type: DEVICE

VisuMax femtosecond laser sphere-only or spherocylindrical treatment

Interventions

Carl Zeiss Meditec VisuMax Femtosecond Laser

VisuMax femtosecond laser sphere-only or spherocylindrical treatment

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Male and female subjects age 22 years of age and older;

2. 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;

3. A stable refraction for the past year, as demonstrated by a change in MRSE of ≤ 0.50 D in the eye to be treated;

4. A difference between cycloplegic and manifest refractions of < 0.75 D spherical equivalent in the eye to be treated;

5. UCVA worse than 20/40 in the eye to be treated;

6. BSCVA at least 20/20 in the eye to be treated;

7. 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;

8. 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;

9. Central corneal thickness of at least 500 microns in the eye to be treated;

10. Willing and able to return for scheduled follow-up examinations;

11. Able to provide written informed consent and follow study instructions in English

Exclusion Criteria

1. Mesopic pupil diameter >8.0 mm;

2. Cylinder > -3.00 D;

3. Treatment depth is less than 250 microns from the corneal endothelium;

4. Eye to be treated is targeted for monovision;

5. Fellow eye has BSCVA worse than 20/40;

6. Keratometry readings via Sim-K values less than 40.00 D;

7. Abnormal corneal topographic findings, e.g. keratoconus, pellucid marginal degeneration in either eye;

8. History of or current anterior segment pathology, including cataracts in the eye to be treated;

9. Clinically significant dry eye syndrome unresolved by treatment in either eye;

10. 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;

11. Ophthalmoscopic signs of progressive or unstable myopia or keratoconus (or keratoconus suspect) in either eye;

12. Irregular or unstable (distorted/not clear) corneal mires on central keratometry images in either eye;

13. History of ocular herpes zoster or herpes simplex keratitis;

14. Deep orbits, strong blink, anxiety, pterygium, or any other finding suggesting difficulty in achieving or maintaining suction;

15. Difficulty following directions or unable to fixate;

16. 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;

17. History of steroid-responsive rise in intraocular pressure, glaucoma, or preoperative IOP > 21 mmHg in either eye;

18. History of diabetes, diagnosed autoimmune disease, connective tissue disease or clinically significant atopic syndrome;

19. Immunocompromised or requires chronic systemic corticosteroids or other immunosuppresive therapy that may affect wound healing;

20. History of known sensitivity to planned study medications;

21. Participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation;

22. Pregnant, lactating, or of child-bearing potential and not practicing a medically approved method of birth control.

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Carl Zeiss Meditec, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dishler Laser Institute

Greenwood Village, Colorado, United States

Discover Vision Centers

Leawood, Kansas, United States

Vance Thompson Vision

Sioux Falls, South Dakota, United States

Slade and Baker Vision Center

Houston, Texas, United States

Davis Duehr Dean

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

VisuMax-2014-1

Identifier Type: -

Identifier Source: org_study_id