Clinical trial NCT01638390: Use of the VisuMax™ Femtosecond Laser
Official title: Use of the VisuMax™ Femtosecond Laser Lenticule Removal Procedure for the Correction of Myopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Myopia
Lead sponsor: Carl Zeiss Meditec, Inc.
Sponsor class: INDUSTRY
First posted: 2012-07-11
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 ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE (Manifest Refractive Spherical Equivalent) ≤ -8.25 D.

Detailed description: This is a prospective multi-center clinical trial in which a total of 360 eyes of consecutive subjects will be enrolled, treated with the VisuMax™ Femtosecond Laser, and followed for a 12-month period. The study will be conducted at up to 8 clinical sites.

Enrollment will be phased such that 100 eyes will be initially enrolled and followed. When 50 of the initial eyes have reached the 3-month follow-up exam, an interim clinical study report will be submitted to FDA along with a request to continue enrollment up to 360 eyes.

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).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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;
* 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 immunosuppressive 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.

Primary outcomes:
measure: Effectiveness- Predictability
timeFrame: 12 months
measure: Effectiveness- Improvement in UCVA Following Treatment
timeFrame: 12 month
measure: Stability Criteria- Change Between Visits Within 1.00 Diopter (D)
timeFrame: 6 months
measure: Safety- Preservation of Best-Spectacle Corrected Visual Acuity (BSCVA)
timeFrame: 12 months
measure: Safety- Induced Manifest Refractive Astigmatism
timeFrame: 12 months
measure: Safety- Adverse Events
timeFrame: 12 months
measure: Safety- Contrast Sensitivity
timeFrame: 12 months
measure: Stability Criteria- Change Between Visits Within 0.50 Diopter (D)
timeFrame: 6 months
Secondary outcomes:
measure: Safety- Patient Symptoms
timeFrame: 12 months
Other outcomes:
Locations:
city: Greenwood Village
country: United States
facility: Dishler Laser Institute
state: Colorado
city: Miami
country: United States
facility: Bascom Palmer Eye Institute
state: Florida
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: Madison
country: United States
facility: Davis Duehr Dean
state: Wisconsin
Study officials:
affiliation: Dishler Laser Institute
name: Jon Dishler, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Discover Vision Centers
name: John Doane, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Vance Thompson Vision Clinic, Prof., LLC
name: Vance Thompson, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bascom Palmer Eye Institute
name: William Culbertson, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bascom Palmer Eye Institute
name: Sonia Yoo, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Davis Duehr Dean
name: John Vukich, M.D.
role: PRINCIPAL_INVESTIGATOR
References: