Clinical Trial With PRECIZON Presbyopic

Prospective Multicenter Clinical Trial With the PRECIZON Presbyopic Multifocal Intraocular Lens

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

Study Overview

• Status: Completed
• Conditions: Cataract; Presbyopia
• Intervention / Treatment: Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Wilrijk, Belgium, 2610
    • Medipolis
• Germany
  • Heidelberg, Germany, 69120
    • Universitäts-Augenklinik Heidelberg
• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 6229 HX
      • Academisch Ziekenhuis Maastricht
• Spain
  • Jerez de la Frontera, Spain, 11408
    • Oftalvist CIO Jerez
  • Terrassa, Spain, 08221
    • Hospital Universitari Mutua Terrassa
• Turkey
  • Istanbul, Turkey, 34457
    • Acibadem Maslak Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm; Bilateral implantation with PRECIZON Presbyopic intraocular lens	Device: PRECIZON Presbyopic; Optical correction of aphakia in adults in whom the crystalline lens has been removed and who desire presbyopia correction.; Other Names: PRECIZON Presbyopic Multifocal intraocular lens (MIOL)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	3 months post-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	3 months post-op
Spectacle dependency	Percentage of patients that achieve complete spectacle independence or occasional use of glasses for near or intermediate vision	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.	3 months post-op
Rates of adverse events and complications		3 months post-op
Patient satisfaction as measured by a patient satisfaction questionnaire		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	3 months post-op

Collaborators and Investigators

• Sponsor: Ophtec BV
• Investigators: Principal Investigator: Mike P. Holzer, Prof. Dr., Heidelberg University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): January 17, 2017
• Study Completion (Actual): January 17, 2017

Study Registration Dates

• First Submitted: March 12, 2015
• First Submitted That Met QC Criteria: April 6, 2015
• First Posted (Estimate): April 7, 2015

Study Record Updates

• Last Update Posted (Actual): April 4, 2017
• Last Update Submitted That Met QC Criteria: April 3, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Refractive Errors; Cataract; Presbyopia
• Other Study ID Numbers: AP01000538

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No