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.
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
357
The reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D.
Dishler Laser Institute
Greenwood Village, Colorado, United States
Bascom Palmer Eye Institute
Miami, Florida, United States
Discover Vision Centers
Leawood, Kansas, United States
Vance Thompson Vision
Sioux Falls, South Dakota, United States
Effectiveness- Predictability of Participant Refractive Outcomes
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.
Time frame: 12 months
Effectiveness- Number of Participants With an 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.
Time frame: 12 month
Stability Criteria- Number of Participants With a 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.
Time frame: 6 months
Safety- Number of Participants With a Preservation of Best-Spectacle Corrected Visual Acuity (BSCVA)
1. 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. 2. Less than 5% of participants with BCVA loss ≥ 2 lines
Time frame: 12 months
Safety- Number of Participants With 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.
Time frame: 12 months
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Davis Duehr Dean
Madison, Wisconsin, United States
Safety- Number of Participants With Adverse Events
Number of participants for each type of adverse event. Target of less than 1% of participants for each type of adverse event.
Time frame: 12 months
Safety- Contrast Sensitivity of Participants
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.
Time frame: 12 months
Stability Criteria- Number of Participants With a 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.
Time frame: 6 months
Safety- Participant 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.
Time frame: 12 months