Clinical Trial With PRECIZON Presbyopic

Cataract Clinical Trial

Official title:

Prospective Multicenter Clinical Trial With the PRECIZON Presbyopic Multifocal Intraocular Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02409771
• Other study ID #: AP01000538
• Status: Completed
• Phase: N/A
• First received: March 12, 2015
• Last updated: April 3, 2017
• Start date: June 2015
• Est. completion date: January 17, 2017

Study information

• Verified date: April 2017
• Source: Ophtec BV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 17, 2017
• Est. primary completion date: January 17, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Presbyopia

Intervention

Device:
• PRECIZON Presbyopic
Optical correction of aphakia in adults in whom the crystalline lens has been removed and who desire presbyopia correction.

Locations

Country	Name	City	State
Belgium	Medipolis	Wilrijk
Germany	Universitäts-Augenklinik Heidelberg	Heidelberg
Netherlands	Academisch Ziekenhuis Maastricht	Maastricht	Limburg
Spain	Oftalvist CIO Jerez	Jerez de la Frontera
Spain	Hospital Universitari Mútua Terrassa	Terrassa
Turkey	Acibadem Maslak Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Ophtec BV

Countries where clinical trial is conducted

Belgium,  Germany,  Netherlands,  Spain,  Turkey, 

Outcome

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