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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05290870

Enrollment

2183

Registered

2022-03-22

Start date

2022-02-01

Completion date

2024-04-30

Last updated

2024-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aphakia, Cataract, Clear Lens Exchange, Refractive Lens Exchange

Keywords

Pseudoaphakia

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.

Interventions

DEVICEPosterior-chamber intraocular lens

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

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Adverse events and adverse device effects	Usual follow-up: 24 Months	—
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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026