A Study With Technolas® TENEO 317 Model 2 Excimer Laser to Treat Participants With Myopia or Myop… (NCT04111757) | Clinical Trial Compass
CompletedNot Applicable
A Study With Technolas® TENEO 317 Model 2 Excimer Laser to Treat Participants With Myopia or Myopic Astigmatism
United States168 participantsStarted 2019-07-25
Plain-language summary
The primary objective of this study is to collect safety and effectiveness data for the Technolas Teneo 317 Model 2 excimer laser for LASIK correction in participants with myopia and myopic astigmatism.
Who can participate
Age range22 Years
SexALL
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Inclusion Criteria:
* Are 22 years of age or older.
* Have read, understood, and signed an informed consent form (ICF).
* Have demonstrated stable refraction (for example, a change of ≤0.5 D in sphere and cylinder) for a minimum of 12 months prior to surgery, verified by consecutive refractions and/or medical records or prescription history.
* Have myopic refractive error with or without astigmatism; sphere between -1.0 D and -10.00 D, cylinder between 0.0 D and -3.0 D; with a manifest refraction spherical equivalent (MRSE) between -1.0 D and -11.50 D.
* Have uncorrected distance visual acuity (UDVA) of 20/40 or worse.
* Have manifest distance best spectacle corrected visual acuity (BSCVA) of 20/25 (logarithm of the minimum angle of resolution \[logMAR\] 0.1) or better in an operative eye.
* Have equal to or less than 0.50 D spherical equivalent (SE) difference between cycloplegic and manifest refractions at Visit 1 (pre-operative).
* Have normal corneal topography as determined by the Investigator.
* Have discontinued use of contact lenses for at least 2 weeks (for hard or toric lenses) or 3 days (for soft contact lenses) prior to the pre-operative 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 2 consecutive examinations at least 1 week apart, in an eye to be treated and the axis of cylinder should not differ by more than 15 degrees from the baseline cycloplegic refracti…
What they're measuring
1
Percentage of Eyes That Achieve MRSE Predictability Within ±0.50 Diopter (D) and ±1.00 D
Timeframe: Assessed at Month 3 to Month 9
2
Percentage of Eyes Targeted for Emmetropia That Achieve Uncorrected Distance Visual Acuity (UDVA) of 20/40 or Better