This phase IV study is an open, prospective, single-center, single-surgeon bilateral eye study to investigate the bilateral uncorrected intermediate visual acuity of presbyopic hyperopic patients, who have been treated with Presbyopia Algorithm SUPRACOR.
The developed software algorithm SUPRACOR uses the subjective refraction of the eye to create a treatment for the distance vision correction. This part of the treatment does not show any difference to a regular LASIK treatment for hyperopic cases. In addition to the treatment for the distance vision an additional central ablation component will be added to address the near vision. Excimer Laser Technolas® 217z100P, High Speed Session Management Software (KERACOR V5.0) and ZYOPTIX Cards as well as all the diagnostic devices that are used in the #1162 study are CE certified and are used for their standard purpose. This study will be conducted at Mater Private Hospital (Eye Laser Department) by Professor Michael O'Keefe who would recruit up to 40 subjects according to the inclusion/exclusion criteria.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
The SUPRACOR algorithm uses the subjective refraction of the eye to create a treatment for the distance vision correction.
Mater Private Hospital, Eye Laser Department
Dublin, Ireland
High contrast intermediate visual acuity
The percentage of treated patients with a binocular uncorrected high contrast intermediate VA of 20/32 (0.4) or better. This percentage should be equal or greater than 60%.
Time frame: The study endpoints will be calculated for the 6-Month follow-up examination.
Contrast sensitivity
For all treated patients the mean value of the binocular photopic contrast sensitivity (log) for the various spatial frequencies should not decrease more than 0.30.
Time frame: The study endpoints will be calculated for the 3-Month and 6-Month follow-up examination. The defined study endpoints should be fulfilled at least for the final examination at 6-Month.
Patient satisfaction
The percentage of satisfied patient post SUPRACOR treatment. This percentage should be equal or greater than 75%.
Time frame: The study endpoints will be calculated for the 3-Month and 6-Month follow-up examination. The defined study endpoints should be fulfilled at least for the final examination at 6-Month.
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