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

NCT05290870 | Completed DMC

• 1 other identifier: PMCF-01-ACX-HS-2022
• Study Type: observational
• Target: 2,183
• Locations: 1 country
• Sites: 1

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.

Conditions

Aphakia; Cataract; Clear Lens Exchange; Refractive Lens Exchange

Keywords

Pseudoaphakia

Outcome Measures

Primary Outcomes (1)

• Visual acuity (uncorrected and/or corrected)

  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 Outcomes (2)

• Adverse events and adverse device effects

  Usual follow-up: 24 Months

• Patient and user satisfaction

  Month 1

Study Arms (2)

Subjects implanted with hydrophilic acrylic IOLs

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

Device: Posterior-chamber intraocular lens

Subjects implanted with hydrophobic acrylic IOLs

Subjects were implanted with an ACUNEX IOL

Device: Posterior-chamber intraocular lens

Interventions

Posterior-chamber intraocular lens DEVICE

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

Subjects implanted with hydrophilic acrylic IOLs; Subjects implanted with hydrophobic acrylic IOLs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Teleon Surgical B.V.: lead
• MaganaMed GmbH: collaborator

Study Sites (1)

Teleon Surgical B.V.

Spankeren, AV, 6956, Netherlands

Location

MeSH Terms

Conditions

Aphakia; Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: March 22, 2022
• Study Start: February 1, 2022
• Primary Completion: February 29, 2024
• Study Completion: April 30, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)