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

Completed

• Conditions: Cataract; Aphakia; Clear Lens Exchange; Refractive Lens Exchange
• Interventions: Device: Posterior-chamber intraocular lens

• Registration Number: NCT05290870
• Lead Sponsor: Teleon Surgical B.V.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-01
• Study First Submitted: 2022-03-11
• Study First Submitted QC: 2022-03-21
• Study First Posted: 2022-03-22
• Primary Completion: 2024-02-29
• Study Completion: 2024-04-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2183

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects implanted with hydrophobic acrylic IOLs	Posterior-chamber intraocular lens	Subjects were implanted with an ACUNEX IOL
Subjects implanted with hydrophilic acrylic IOLs	Posterior-chamber intraocular lens	Subjects were implanted with a HydroSmart IOL (FEMTIS, LENTIS or VISIOTIS)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Teleon Surgical B.V.; 🇳🇱 Spankeren, AV, Netherlands