NCT02409771

Brief Summary

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

Geographic Reach
5 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2015

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 7, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2017

Completed
Last Updated

April 4, 2017

Status Verified

April 1, 2017

Enrollment Period

1.6 years

First QC Date

March 12, 2015

Last Update Submit

April 3, 2017

Conditions

CataractPresbyopia

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (8)

  • Photopic contrast sensitivity as measured by a contrast sensitivity chart

    3 months postoperative

  • Mesopic contrast sensitivity as measured by a contrast sensitivity chart

    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

    3 months post-op

  • Spectacle dependency

    3 months post-op

  • Defocus curve

    3 months post-op

  • +3 more secondary outcomes

Study Arms (1)

Intervention arm

EXPERIMENTAL

Bilateral implantation with PRECIZON Presbyopic intraocular lens

Device: PRECIZON Presbyopic

Interventions

PRECIZON PresbyopicDEVICE

Optical correction of aphakia in adults in whom the crystalline lens has been removed and who desire presbyopia correction.

Also known as: PRECIZON Presbyopic Multifocal intraocular lens (MIOL)
Intervention arm

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Medipolis

Wilrijk, 2610, Belgium

Location

Universitäts-Augenklinik Heidelberg

Heidelberg, 69120, Germany

Location

Academisch Ziekenhuis Maastricht

Maastricht, Limburg, 6229 HX, Netherlands

Location

Oftalvist CIO Jerez

Jerez de la Frontera, 11408, Spain

Location

Hospital Universitari Mútua Terrassa

Terrassa, 08221, Spain

Location

Acibadem Maslak Hospital

Istanbul, 34457, Turkey (Türkiye)

Location

MeSH Terms

Conditions

CataractPresbyopia

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesRefractive Errors

Study Officials

  • Mike P. Holzer, Prof. Dr.

    Heidelberg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2015

First Posted

April 7, 2015

Study Start

June 1, 2015

Primary Completion

January 17, 2017

Study Completion

January 17, 2017

Last Updated

April 4, 2017

Record last verified: 2017-04

Locations

BE(1)DE(1)ES(2)TU(1)NL(1)