Use of the VisuMax™ Femtosecond Laser

Study Overview
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Brief Summary
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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
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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).

Official Title
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Use of the VisuMax™ Femtosecond Laser Lenticule Removal Procedure for the Correction of Myopia

Conditions
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Myopia

Intervention / Treatment
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* Device: Treatment with the VisuMax™ Femtosecond Laser


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treatment of Myopia<br>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<br>* The reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D.<br>* Other names: VisuMaxTM Femtosecond Laser;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness- Predictability | 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- 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- 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- Preservation of Best-Spectacle Corrected Visual Acuity (BSCVA) | 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. Less than 5% of participants with BCVA loss ≥ 2 lines | 12 months | 
| Safety- 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- 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 | 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- 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety- Patient Symptoms | A standardized quality of vision (QoV) questionnaire was used in the study. A score is generated and was used to compare the results from baseline to the 12 month visit. Number of participants who improved, stayed the same, or worsened with regards to the frequency, severity, and bothersomeness of symptoms are reported. | 12 months |