A Prospective Safety and Effectiveness Study of the 500 Hz Technolas Perfect Vision Excimer Laser… (NCT01977807) | Clinical Trial Compass
UnknownPhase 4
A Prospective Safety and Effectiveness Study of the 500 Hz Technolas Perfect Vision Excimer Laser in Asian Eyes Using LASIK
Philippines100 participantsStarted 2014-08
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.
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.
General 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.
* Subjects have to be willing and able to return for scheduled follow-up examinations for up to 6 and 12 months respectively after surgery.
* Corneal topography should be qualified
* High contrast, manifest, best spectacle-corrected distance visual acuity correctable binocular to at least 1.0 (Snellen 20/20 or 6/6) and monocular to at least 0.8 (Snellen 20/25 or 6/7.5). In case of a monocular surgery the eye which should not be treated must have a best corrected distance visual acuity of at least 0.8 (Snellen 20/25 or 6/7.5).
* Mesopic pupil size measured with the Zywave II WaveFront Aberrometer must be \< 7.0 mm and photopic pupil size measured with the Orbscan II/ IIz must be \> 2.9 mm.
Additional Inclusion Criteria for Proscan Treatments
* For Proscan myopic subjects require a sphere between -0.5 D up to -10.0 D and cylinder between -0.5 D up to -4.0 D (not corneal astigmatism) and SE up to -12.0 D
* For Proscan hyperopic subjects require a sphere between +0.5 D up to +4.0 D and cylinder between +0.5 D up to +4.0 D (not corneal astigmatism) and SE up to +6.0 D.
Additional Inclusion Criteria for Zyoptix Treatments
For Zyoptix myopic subjects require a sphere between -0.5 D up to -10.0 D and cylinder between -0.5 D up to -4.0 D (not corneal astigmatism) and SE up to -12.0 D
* For Zyoptix hyperopic subjects …
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