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

Sponsor
Teleon Surgical B.V. (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05290870
Collaborator
medXteam GmbH (Other), MaganaMed GmbH (Other)
1,000
1
24
41.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Posterior-chamber intraocular lens

Study Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Registry Study on Hydrophilic (HydroSmart) and Hydrophobic (ACUNEX) Intraocular Lenses Manufactured by Teleon Surgical B.V.
Actual Study Start Date :
Feb 1, 2022
Anticipated Primary Completion Date :
Jan 31, 2024
Anticipated Study Completion Date :
Jan 31, 2024

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Visual acuity (uncorrected and/or corrected) [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 Outcome Measures

  1. Adverse events and adverse device effects [Usual follow-up: 24 Months]

  2. Patient and user satisfaction [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Teleon Surgical B.V. Spankeren AV Netherlands 6956

Sponsors and Collaborators

  • Teleon Surgical B.V.
  • medXteam GmbH
  • MaganaMed GmbH

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Teleon Surgical B.V.
ClinicalTrials.gov Identifier:
NCT05290870
Other Study ID Numbers:
  • PMCF-01-ACX-HS-2022
First Posted:
Mar 22, 2022
Last Update Posted:
Apr 29, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Teleon Surgical B.V.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 29, 2022