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Clinical Trial With PRECIZON Presbyopic

Primary Purpose

Cataract, Presbyopia

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

PRECIZON Presbyopic

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Medipolis
Universitäts-Augenklinik Heidelberg
Academisch Ziekenhuis Maastricht
Oftalvist CIO Jerez
Hospital Universitari Mútua Terrassa
Acibadem Maslak Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention arm

Arm Description

Bilateral implantation with PRECIZON Presbyopic intraocular lens

Outcomes

Primary Outcome Measures

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

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

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

Secondary Outcome Measures

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.

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.

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

Spectacle dependency

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

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.

Rates of adverse events and complications

Patient satisfaction as measured by a patient satisfaction questionnaire

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

Full Information

NCT ID

NCT02409771

First Posted

March 12, 2015

Last Updated

April 3, 2017

Sponsor

Ophtec BV

1. Study Identification

Unique Protocol Identification Number

NCT02409771

Brief Title

Clinical Trial With PRECIZON Presbyopic

Official Title

Prospective Multicenter Clinical Trial With the PRECIZON Presbyopic Multifocal Intraocular Lens

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

June 2015 (Actual)

Primary Completion Date

January 17, 2017 (Actual)

Study Completion Date

January 17, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ophtec BV

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cataract, Presbyopia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention arm

Arm Type

Experimental

Arm Description

Bilateral implantation with PRECIZON Presbyopic intraocular lens

Intervention Type

Device

Intervention Name(s)

PRECIZON Presbyopic

Other Intervention Name(s)

PRECIZON Presbyopic Multifocal intraocular lens (MIOL)

Intervention Description

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

Primary Outcome Measure Information:

Title

Improvement in monocular and binocular uncorrected and corrected near visual acuity

Description

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

Time Frame

3 months follow-up postoperative

Title

Improvement in monocular and binocular uncorrected and corrected intermediate visual acuity

Description

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

Time Frame

3 months post-op

Title

Improvement in monocular and binocular uncorrected and corrected distance visual acuity

Description

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

Time Frame

3 months post-op

Secondary Outcome Measure Information:

Title

Photopic contrast sensitivity as measured by a contrast sensitivity chart

Description

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

Time Frame

3 months postoperative

Title

Mesopic contrast sensitivity as measured by a contrast sensitivity chart

Description

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

Time Frame

3 months post-op

Title

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

Description

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

Time Frame

3 months post-op

Title

Spectacle dependency

Description

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

Time Frame

3 months post-op

Title

Defocus curve

Description

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.

Time Frame

3 months post-op

Title

Rates of adverse events and complications

Time Frame

3 months post-op

Title

Patient satisfaction as measured by a patient satisfaction questionnaire

Time Frame

3 months post-op

Title

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

Description

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

Time Frame

3 months post-op

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mike P. Holzer, Prof. Dr.

Organizational Affiliation

Heidelberg University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medipolis

City

Wilrijk

ZIP/Postal Code

2610

Country

Belgium

Facility Name

Universitäts-Augenklinik Heidelberg

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

Academisch Ziekenhuis Maastricht

City

Maastricht

State/Province

Limburg

ZIP/Postal Code

6229 HX

Country

Netherlands

Facility Name

Oftalvist CIO Jerez

City

Jerez de la Frontera

ZIP/Postal Code

11408

Country

Spain

Facility Name

Hospital Universitari Mútua Terrassa

City

Terrassa

ZIP/Postal Code

08221

Country

Spain

Facility Name

Acibadem Maslak Hospital

City

Istanbul

ZIP/Postal Code

34457

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Clinical Trial With PRECIZON Presbyopic

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