Registry Study on Intraocular Lenses Manufactured by Teleon Surgical B.V.

July 1, 2024 updated by: Teleon Surgical B.V.

Registry Study on Hydrophilic (HydroSmart) and Hydrophobic (ACUNEX) Intraocular Lenses Manufactured by Teleon Surgical B.V.

This is a retrospective, observational (Registry) study aiming to collect safety and performance data on the use of intraocular lenses (IOLs) manufactured by Teleon Surgical B.V. according to routine practice.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2183

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

  • Netherlands
    • AV
      • Spankeren, AV, Netherlands, 6956
        • Teleon Surgical B.V.

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients who have undergone uni- or bilateral extraction of the crystalline lens by means of phacoemulsification or femtosecond laser-assisted cataract surgery with implantation of the subject IOL.

Description

Inclusion Criteria:

  • Patients older than 18 years
  • Diagnosis of cataract in at least one eye or seeking clear/refractive lens exchange
  • Provide consent to retrospective data collection

Exclusion Criteria:

  • Patients younger than 18 years
  • Patients with congenital primary aphakia or secondary aphakia

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Subjects implanted with hydrophilic acrylic IOLs
Subjects were implanted with a HydroSmart IOL (FEMTIS, LENTIS or VISIOTIS)
Device: Posterior-chamber intraocular lens
Implantation of a posterior-chamber intraocular lens to correct aphakia after removal of the crystalline lens
Subjects implanted with hydrophobic acrylic IOLs
Subjects were implanted with an ACUNEX IOL
Device: Posterior-chamber intraocular lens
Implantation of a posterior-chamber intraocular lens to correct aphakia after removal of the crystalline lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual acuity (uncorrected and/or corrected)
Time Frame: Preoperatively to Month 24

Monocular visual acuity measured under photopic conditions from preoperative to Month 24 using standard methods (e.g. Snellen Chart 6/6-metre, 1.0 decimal or 0.0 logMAR) at standard distances (4 m for far, 65-80 cm for intermediate and 35-40 cm for near distance), depending on IOL optical design, as follows:

For monofocal IOLs:

• Uncorrected and corrected distance visual acuity

For monofocal toric IOLs:

  • Uncorrected and corrected distance visual acuity
  • Residual astigmatism
  • IOL rotation

For multifocal IOLs:

  • Uncorrected and corrected distance visual acuity
  • Uncorrected and corrected near visual acuity
  • Uncorrected and corrected intermediate visual acuity, if available

For multifocal toric IOLs:

  • Uncorrected and corrected distance visual acuity
  • Uncorrected and corrected near visual acuity
  • Uncorrected and corrected intermediate visual acuity, if available
  • Residual astigmatism
  • IOL rotation
Preoperatively to Month 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events and adverse device effects
Time Frame: Usual follow-up: 24 Months
Usual follow-up: 24 Months
Patient and user satisfaction
Time Frame: Month 1
Satisfaction of the patient with the outcomes of the procedure/medical device Satisfaction of the user with handling of the medical device and patients outcomes
Month 1

Collaborators and Investigators

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

Sponsor

Teleon Surgical B.V.

Collaborators

MaganaMed GmbH

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)

February 1, 2022

Primary Completion (Actual)

February 29, 2024

Study Completion (Actual)

April 30, 2024

Study Registration Dates

First Submitted

March 11, 2022

First Submitted That Met QC Criteria

March 21, 2022

First Posted (Actual)

March 22, 2022

Study Record Updates

Last Update Posted (Actual)

July 3, 2024

Last Update Submitted That Met QC Criteria

July 1, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PMCF-01-ACX-HS-2022

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.

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