Clinical Trial With PRECIZON Presbyopic

Ophtec

Status

Completed

Conditions

Cataract

Presbyopia

Treatments

Device: PRECIZON Presbyopic

Study type

Interventional

Funder types

Industry

Identifiers

NCT02409771

AP01000538

Details and patient eligibility

About

The purpose of this clinical trial is to evaluate the effectiveness of the PRECIZON Presbyopic.

Full description

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.

Enrollment

70 patients

Sex

All

Ages

45+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Presbyopic
Cataract patient or Clear Lens Extraction (CLE) candidate
Patients wishes to be spectacle independent for near and far vision
Patient lifestyle and outlook fit with multifocal IOL implantation
Qualifies for bilateral implantation
Patient must have a calculated IOL power within the available diopter range
Expected best corrected visual acuity of 0.5 Snellen decimal or better after IOL implantation.
No secondary surgical procedure planned during the course of the study
Availability, willingness and sufficient cognitive awareness and physical ability to comply with examination procedures throughout the entire duration of the study
Patients must provide written informed consent
The predicted keratometric postoperative astigmatism (calculated with respect to the surgical induced astigmatism) must be <1.0 D.

Exclusion criteria

Ocular disease other than cataract that may predispose for future complications or might confound the outcome of the investigation (e.g. anterior segment pathology, glaucoma, corneal dystrophy, ocular inflammation, pseudoexfoliation syndrome, retinal disorders)
Acute or chronic disease or illness or use of medication that could confound the outcome of the study or increase the risk to the subject
Endothelial cell count <1500 cells/mm2
Amblyopia
Congenital eye abnormalities
Previous ocular surgery that might confound the outcome of the investigation or increase risk to patient
Concurrent participation or participation during the last 30 days in any other clinical trial
Patient must not be pregnant or has another condition with associated fluctuation of hormones that could lead to refractive changes