Clinical trial NCT02409771: Clinical Trial With PRECIZON Presbyopic
Official title: Prospective Multicenter Clinical Trial With the PRECIZON Presbyopic Multifocal Intraocular Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Presbyopia
Lead sponsor: Ophtec BV
Sponsor class: INDUSTRY
First posted: 2015-04-07
Enrollment: 70
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Improvement in monocular and binocular uncorrected and corrected near visual acuity
timeFrame: 3 months follow-up postoperative
measure: Improvement in monocular and binocular uncorrected and corrected intermediate visual acuity
timeFrame: 3 months post-op
measure: Improvement in monocular and binocular uncorrected and corrected distance visual acuity
timeFrame: 3 months post-op
Secondary outcomes:
measure: Photopic contrast sensitivity as measured by a contrast sensitivity chart
timeFrame: 3 months postoperative
measure: Mesopic contrast sensitivity as measured by a contrast sensitivity chart
timeFrame: 3 months post-op
measure: Stability of manifest refraction (MRSE) as measured by a mean change in MRSE between visits as determined by a paired analysis
timeFrame: 3 months post-op
measure: Spectacle dependency
timeFrame: 3 months post-op
measure: Defocus curve
timeFrame: 3 months post-op
measure: Rates of adverse events and complications
timeFrame: 3 months post-op
measure: Patient satisfaction as measured by a patient satisfaction questionnaire
timeFrame: 3 months post-op
measure: Quality of vision as measured by the Quality of Vision (QoV) questionnaire
timeFrame: 3 months post-op
Other outcomes:
Locations:
city: Wilrijk
country: Belgium
facility: Medipolis
city: Heidelberg
country: Germany
facility: Universitäts-Augenklinik Heidelberg
city: Maastricht
country: Netherlands
facility: Academisch Ziekenhuis Maastricht
state: Limburg
city: Jerez de la Frontera
country: Spain
facility: Oftalvist CIO Jerez
city: Terrassa
country: Spain
facility: Hospital Universitari Mútua Terrassa
city: Istanbul
country: Turkey
facility: Acibadem Maslak Hospital
Study officials:
affiliation: Heidelberg University
name: Mike P. Holzer, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: