A cataract is the clouding of the natural lens in the eye and is very common as when getting older. A cloudy lens makes it difficult to see. A cataract is treated by removing the cloudy lens and replacing it with an intraocular lens (known as an IOL). The goal of this clinical trial is to determine if the Eyedeal® IOL can be safely implanted in a subject's eye and if it can replace efficiently the natural lens. Subjects will be asked to attend a total of seven visits for this study for a period of 12 months after surgery.
To investigate the safety and performance of the Eyedeal® PX65AS1 intraocular lens (IOL) * To evaluate the safety profile with regards to best-corrected visual acuity, and adverse events * To evaluate the performance with regards of best corrected distance VA after the device implantation The Eyedeal® IOL (PX65AS1) is a foldable single-piece ultra-violet absorbing posterior chamber intraocular lens (IOL). It is an optical implant to replace the human crystalline lens in the visual correction of aphakia in adult patients after cataract removal. The Eyedeal® PX65AS1 IOL lens is made of a high refractive index soft cross-linked polyolefin. The Eyedeal® PX65AS1 IOL lens has an aspheric optic with symmetric optic design and spherical neutral and correct lens's own spherical aberration supporting haptics to provide proper position of the IOL optic within the capsule.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
97
Subjects will undergo surgery to remove cataract (the cloudy lenses) via phacoemulsification, and implant the Eyedeal® Model PX65AS1 IOL in the eye capsule.
Subjects will undergo surgery to remove cataract (the cloudy lenses) via phacoemulsification, and implant the Eyedeal® Model PX65AS1 IOL in the eye capsule.
University Eye Clinic Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
NOT_YET_RECRUITINGDepartment of Ophthalmology, Hospital of Lithuanian University of Health Sciences Kauno klinikos
Kaunas, Lithuania
RECRUITINGEFFICACY OUTCOME MEASURE - Uncorrected Distance Visual Acuity
Uncorrected distance Visual Acuity is measured in accordance with ISO 11979-7:2018 - Appendix E: BCVA 20/40 or better in 95% of cases. The stability and consistency of visual results will be measured over time.
Time frame: 12 months
SAFETY OUTCOME MEASURE - Best Corrected Visual Acuity
The safety of the Eyedeal® Model PX65AS1 IOLs (Xi'an Eyedeal Medical Technology Co., Ltd.) will be measured by the following criteria: Loss of BCDVA measured in accordance with ISO 11979-7:2018-Appendix E
Time frame: 12 months
SAFETY OUTCOME MEASURE - Evaluation of Patient record
The safety of the Eyedeal® Model PX65AS1 IOLs (Xi'an Eyedeal Medical Technology Co., Ltd.) will be measured by the following criteria: Patient record of inflammation, discomfort, or pain following surgery related to the Eyedeal® Model PX65AS1 IOL (Xi'an Eyedeal Medical Technology Co., Ltd.) . .
Time frame: 12 months
SAFETY OUTCOME MEASURE - Evaluation of Adverse Events
The safety of the Eyedeal® Model PX65AS1 IOLs (Xi'an Eyedeal Medical Technology Co., Ltd.) will be measured by the following criteria: Evaluation of all adverse events, adverse device effects and device deficiencies at post-operative examinations
Time frame: 12 months
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