PMCF Retrospective Study Outcomes of a Premium Monofocal IOL (PHY2110)

July 19, 2022 updated by: Beaver-Visitec International, Inc.

Clinical Study to Investigate Visual Performance, Contrast Sensitivity and Patient Satisfaction After Implantation of a Premium Monofocal Intraocular Lens

Multicentric, retro- / prospective, open-label, observational PMCF study to investigate visual performance, contrast sensitivity and patient satisfaction after mono- or bilateral implantation of Isopure 1.2.3. intraocular lenses following cataract surgery.

The study treatment itself is not part of this observational clinical investigation. Only patients that already have been implanted with the device under investigation qualify for this retro- prospective observational clinical study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study is a multicentric, retro- / prospective, open-label, observational PMCF study to investigate visual performance, contrast sensitivity and patient satisfaction after mono- or bilateral implantation of Isopure 1.2.3. intraocular lenses following cataract surgery.

The study treatment itself is not part of this observational clinical investigation. Only patients that already have been implanted with the device under investigation qualify for this retro- prospective observational clinical study.

Isopure 1.2.3. is CE approved and commercially available in the countries this clinical investgation is being carried out. The investigational device and all study products, including the devices used for the study examinations, will be used within the intended use specifications from the manufacturer. In addition, no invasive or other burdening examinations will occur for the patient.

The study will be carried out in up to five clinical centers in Spain. The device under investigation (Isopure 1.2.3.) is a hydrophobic, glistening-free, acrylic Premium Monofocal intraocular lens (IOL) manufactured by the sponsor of this study, PhysIOL sa/nv.

Subjects participating in the trial will attend a total of maximum 1 study visit (from 120 days post-operative). This study visit will be minimum 20 days after the surgery of the 2nd eye. Subjects would have the option for unscheduled visits if required medically.

The primary performance endpoint is to show that the monocular Best Corrected Distance Visual Acuity (CDVA) measured in the study group is statistically non-inferior to outcomes of the monofocal parent lens Micropure 1.2.3. The comparative data is used from the latest Clinical Evaluation Report (CER) for the monofocal Micropure 1.2.3. lens. To avoid bias, only the first implanted eye will be considered for this calculation. Data interim analyses will be done after the last patient finished the 1 study visit postoperative examination to support the study publication plan.

Study Type

Interventional

Enrollment (Actual)

109

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alicante, Spain
        • Oftalvist, Alicante
      • Alicante, Spain
        • Vithas, Alicante
      • Madrid, Spain
        • Clinica Baviera
      • Madrid, Spain
        • HM Monteprincipe
      • Madrid, Spain
        • HM Vallés
      • Multiple Locations, Spain
        • Augenklinik, Palma de Mallorca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • • Male or female adults ages 45 years or older on the day of treatment that were mono- or bilaterally implanted with Isopure 1.2.3. intraocular lens minimum 120 days before the study visit;
  • Maximum time between first and second eye treatment: 45 days (this accounts for bilateral implantations only);
  • Capability to understand and sign an IRB approved informed consent form and privacy authorization;
  • Clear intraocular media;
  • Minimum set of retrospective preoperative and intraoperative data available as outlined in the examination matrix;
  • Willing and able to conform to the study requirements.

Exclusion Criteria:

  • • Age of patient <45 years at the day of surgery;
  • Time between first and second eye treatment: >45 days (this accounts for bilateral implantations only);
  • Subjects who underwent previous intraocular or corneal surgery other than IOL implantation;
  • Subjects with diagnosed degenerative visual disorders (e.g. AMD or CME);
  • Subjects in whom in-the-bag implantation was not possible;
  • Subjects in whom surgical complications occurred (e.g. posterior rupture).
  • Subjects showing glaucoma;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IOL retrospective data collection
Experimental arm: Premium Monofocal intraocular lens.
Device: IOL implantation experimental (Isopure 1.2.3.)
Implantation of Premium Monofocal Isopure 12.3 with retrospective data collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
monocular Best Corrected Distance Visual Acuity (CDVA) under photopic light conditions on the first implanted eye.
Time Frame: From 120 days postoperative
No statistically significant difference between the monocular CDVA from 4 months follow up visit when compared to the parent IOL (Micropure 1.2.3). A significance level of 0.025 or lower (p < 0.025) will be considered statistically significant. CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2018.
From 120 days postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beaver-Visitec International, Inc.

Collaborators

targomedGmbH

Investigators

  • Principal Investigator: Gonzalo Bernabeu Arias, MD, HM Monteprincipe, HM Vallés, Madrid, Spain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2021

Primary Completion (Actual)

January 12, 2022

Study Completion (Actual)

January 12, 2022

Study Registration Dates

First Submitted

April 29, 2021

First Submitted That Met QC Criteria

April 30, 2021

First Posted (Actual)

May 5, 2021

Study Record Updates

Last Update Posted (Actual)

July 20, 2022

Last Update Submitted That Met QC Criteria

July 19, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHY2110

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cataract

Clinical Trials on IOL implantation experimental (Isopure 1.2.3.)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe