The purpose of this clinical trial is to evaluate the effectiveness of the PRECIZON Presbyopic.
Prospective, open-label, single-arm, multicenter clinical evaluation with a 3 months follow-up. The PRECIZON Presbyopic is a lens intended for implantation in the capsular bag, indicated for optical correction of aphakia in adults whom the crystalline lens has been removed and who desire presbyopia correction. The main objective is to evaluate the ability of the PRECIZON Presbyopic to provide near, intermediate and distance vision in patients undergoing cataract extraction / Clear Lens Exchange (CLE) and intraocular lens implantation. Study results will be used for CE-approval and registration and marketing purposes.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Optical correction of aphakia in adults in whom the crystalline lens has been removed and who desire presbyopia correction.
Medipolis
Wilrijk, Belgium
Universitäts-Augenklinik Heidelberg
Heidelberg, Germany
Academisch Ziekenhuis Maastricht
Maastricht, Limburg, Netherlands
Oftalvist CIO Jerez
Jerez de la Frontera, Spain
Improvement in monocular and binocular uncorrected and corrected near visual acuity
The ability of the PRECIZON Presbyopia Intraocular lens (IOL) to provide near visual acuity
Time frame: 3 months follow-up postoperative
Improvement in monocular and binocular uncorrected and corrected intermediate visual acuity
The ability of the PRECIZON Presbyopia Intraocular lens (IOL) to provide intermediate visual acuity
Time frame: 3 months post-op
Improvement in monocular and binocular uncorrected and corrected distance visual acuity
The ability of the PRECIZON Presbyopia Intraocular lens (IOL) to provide distance visual acuity
Time frame: 3 months post-op
Photopic contrast sensitivity as measured by a contrast sensitivity chart
Binocular contrast sensitivity scores for spatial frequencies of 3.0 cpd, 6.0 cpd, 12.0 cpd and 18.0 cpd.
Time frame: 3 months postoperative
Mesopic contrast sensitivity as measured by a contrast sensitivity chart
Binocular contrast sensitivity scores for spatial frequencies of 3.0 cpd, 6.0 cpd, 12.0 cpd and 18.0 cpd.
Time frame: 3 months post-op
Stability of manifest refraction (MRSE) as measured by a mean change in MRSE between visits as determined by a paired analysis
Percentage of eyes that achieve a change of less than or equal to 1.00 D of MRSE between two refractions performed 3 months apart
Time frame: 3 months post-op
Spectacle dependency
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Hospital Universitari Mútua Terrassa
Terrassa, Spain
Acibadem Maslak Hospital
Istanbul, Turkey (Türkiye)
Percentage of patients that achieve complete spectacle independence or occasional use of glasses for near or intermediate vision
Time frame: 3 months post-op
Defocus curve
Binocular defocus evaluation will be obtained by using the best corrected distance refraction and then defocusing the image in 0.5 D increments to -0.5 D.
Time frame: 3 months post-op
Rates of adverse events and complications
Time frame: 3 months post-op
Patient satisfaction as measured by a patient satisfaction questionnaire
Time frame: 3 months post-op
Quality of vision as measured by the Quality of Vision (QoV) questionnaire
Percentage of patients with a QoV score \>10 and \>30 at 3 months postoperative
Time frame: 3 months post-op