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

Teleon Surgical

Status: Completed

Conditions: Clear Lens Exchange; Cataract; Refractive Lens Exchange; Aphakia

Treatments: Device: Posterior-chamber intraocular lens

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT05290870

PMCF-01-ACX-HS-2022

Details and patient eligibility

About

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.

Enrollment: 2,183 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2,183 participants in 2 patient groups

Subjects implanted with hydrophilic acrylic IOLs

Description:

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

Treatment:

Device: Posterior-chamber intraocular lens

Subjects implanted with hydrophobic acrylic IOLs

Description:

Subjects were implanted with an ACUNEX IOL

Treatment:

Device: Posterior-chamber intraocular lens