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

NCT ID: NCT05290870

Last Updated: 2024-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2183 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-01

Study Completion Date

2024-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Aphakia Cataract Clear Lens Exchange Refractive Lens Exchange

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Subjects implanted with hydrophilic acrylic IOLs

Subjects were implanted with a HydroSmart IOL (FEMTIS, LENTIS or VISIOTIS)

Posterior-chamber intraocular lens

Intervention Type DEVICE

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

Posterior-chamber intraocular lens

Intervention Type DEVICE

Implantation of a posterior-chamber intraocular lens to correct aphakia after removal of the crystalline lens

Interventions

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Posterior-chamber intraocular lens

Implantation of a posterior-chamber intraocular lens to correct aphakia after removal of the crystalline lens

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MaganaMed GmbH

UNKNOWN

Sponsor Role collaborator

Teleon Surgical B.V.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Teleon Surgical B.V.

Spankeren, AV, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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PMCF-01-ACX-HS-2022

Identifier Type: -

Identifier Source: org_study_id

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