Hyperopic Presbyopia Clinical Trial
Official title:
PHASE IV STUDY # 1162. Prospective Investigation of SUPRACOR Visual Outcomes of Presbyopic Hyperopic Patients With and Without Astigmatism
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.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment