A Prospective Safety and Effectiveness Study of a New High Repetition Rate Excimer Laser Using LA… (NCT02112968) | Clinical Trial Compass
UnknownPhase 4
A Prospective Safety and Effectiveness Study of a New High Repetition Rate Excimer Laser Using LASIK for the Correction of Ammetropia and Presbyopia
97 participantsStarted 2014-12
Plain-language summary
This clinical study has been planned to evaluate the safety and effectiveness of common treatment algorithms using 500 Hz laser repetition rate for the correction of Ammetropia and Presbyopia
Who can participate
Age range18 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects have to be at least 18 years of age.
* Subjects have to be able to read, understand, and sign a statement of Informed Consent (be given a copy of the signed Informed Consent Form (ICF).
* Subjects have to be willing and able to return for scheduled follow-up examinations for up to 6 respectively 12 months after surgery.
* For Proscan and Zyoptix Treatments the myopic subjects require a sphere between -0.5 D up to a maximum sphere of -10.0 D. If the patient has a refractive astigmatism to be treated, this must be between -0.5 D up to -4.0 D (not corneal astigmatism) as expressed in spectacle minus cylinder form (by manifest subjective refraction). Overall the SE for myopes must be no more than -12.0 D.
* The Hyperopic subjects require a sphere between +0.5 D up to a maximum sphere of +4.0 D. If the patient has a refractive astigmatism to be treated, this must be between +0.5 D up to +4.0 D (not corneal astigmatism) as expressed in spectacle plus cylinder form (by manifest subjective refraction). Overall the SE for hyperopes must be no more than +6.0 D.
* Subjects who are contact lens wearers must have gas permeable lenses discontinued for at least 3 weeks and soft lenses discontinued for at least 1 week prior to the pre-operative evaluation in the eye to be treated.
* Corneal topography should be qualified.
* Subjects who are contact lens wearers must have two (2) central keratometry readings and two (2) manifest subjective refractions taken pre…
What they're measuring
1
For Proscan and Zyoptix: - The percentage of treated eyes within +/- 0.50D of target refraction. For Supracor: - The percentage of treated eyes with a best corrected high contrast distance VA of Snellen 20/25 (6/7.5 or 0.1 logMAR) or better