Skip to main content
OpenTrials
Completed

NCT Number: NCT02409771

Clinical Trial With PRECIZON Presbyopic

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cataract Eye Diseases Lens Diseases Presbyopia Refractive Errors

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medipolis, Wilrijk, Belgium

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PRECIZON Presbyopic

Device

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)

Primary outcomes

  1. Improvement in monocular and binocular uncorrected and corrected near visual acuity

    Time frame: 3 months follow-up postoperative

    The ability of the PRECIZON Presbyopia Intraocular lens (IOL) to provide near visual acuity

  2. Improvement in monocular and binocular uncorrected and corrected intermediate visual acuity

    Time frame: 3 months post-op

    The ability of the PRECIZON Presbyopia Intraocular lens (IOL) to provide intermediate visual acuity

  3. Improvement in monocular and binocular uncorrected and corrected distance visual acuity

    Time frame: 3 months post-op

    The ability of the PRECIZON Presbyopia Intraocular lens (IOL) to provide distance visual acuity

Secondary outcomes

  1. Photopic contrast sensitivity as measured by a contrast sensitivity chart

    Time frame: 3 months postoperative

    Binocular contrast sensitivity scores for spatial frequencies of 3.0 cpd, 6.0 cpd, 12.0 cpd and 18.0 cpd.

  2. Mesopic contrast sensitivity as measured by a contrast sensitivity chart

    Time frame: 3 months post-op

    Binocular contrast sensitivity scores for spatial frequencies of 3.0 cpd, 6.0 cpd, 12.0 cpd and 18.0 cpd.

  3. Stability of manifest refraction (MRSE) as measured by a mean change in MRSE between visits as determined by a paired analysis

    Time frame: 3 months post-op

    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

  4. Spectacle dependency

    Time frame: 3 months post-op

    Percentage of patients that achieve complete spectacle independence or occasional use of glasses for near or intermediate vision

  5. Defocus curve

    Time frame: 3 months post-op

    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.

  6. Rates of adverse events and complications

    Time frame: 3 months post-op

  7. Patient satisfaction as measured by a patient satisfaction questionnaire

    Time frame: 3 months post-op

  8. Quality of vision as measured by the Quality of Vision (QoV) questionnaire

    Time frame: 3 months post-op

    Percentage of patients with a QoV score >10 and >30 at 3 months postoperative

Sponsors and collaborators

Lead sponsor

Ophtec BV

Industry

Registry information

Official study title

Prospective Multicenter Clinical Trial With the PRECIZON Presbyopic Multifocal Intraocular Lens

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 7, 2015
Registry last updated
Apr 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.