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OpenTrials
Completed

NCT Number: NCT05290870

Registry Study on 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.

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Key information

Conditions

Aphakia Cataract Clear Lens Exchange Eye Diseases Lens Diseases Refractive Lens Exchange

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Teleon Surgical B.V.

Spankeren, AV, 6956, Netherlands

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Posterior-chamber intraocular lens

Device

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Adverse events and adverse device effects

    Time frame: Usual follow-up: 24 Months

  2. 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

Sponsors and collaborators

Lead sponsor

Teleon Surgical B.V.

Industry

Collaborators

  • MaganaMed GmbH

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 22, 2022
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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