Clinical trial NCT02430428: Correction of Myopia Wtih or Without Astigmatism Using the VisuMax™ Femtosecond Laser
Official title: Use of the VisuMax™ Femtosecond Laser Lenticule Removal Procedure for the Correction of Myopia Wtih or Without Astigmatism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Astigmatism
Lead sponsor: Carl Zeiss Meditec, Inc.
Sponsor class: INDUSTRY
First posted: 2015-04-30
Enrollment: 357
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of subjects with MRSE within ± 1.00 D and ± 0.50 D
timeFrame: 1 Year
measure: Improvement in UCVA following treatment
timeFrame: 1 Year
measure: Preservation of Best-Spectacle Corrected Visual Acuity (BSCVA)
timeFrame: 1 Year
measure: Number of subjects with induced MRCyl > 2.00 D
timeFrame: 1 Year
measure: Incidence of Adverse Events
timeFrame: 1 Year
measure: Change in Contrast Sensitivity
timeFrame: 1 Year
Secondary outcomes:
measure: Patient Symptoms
timeFrame: 1 Year
Other outcomes:
Locations:
city: Greenwood Village
country: United States
facility: Dishler Laser Institute
state: Colorado
city: Leawood
country: United States
facility: Discover Vision Centers
state: Kansas
city: Sioux Falls
country: United States
facility: Vance Thompson Vision
state: South Dakota
city: Houston
country: United States
facility: Slade and Baker Vision Center
state: Texas
city: Madison
country: United States
facility: Davis Duehr Dean
state: Wisconsin
Study officials:
References: