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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05290870
• Other study ID #: PMCF-01-ACX-HS-2022
• Status: Enrolling by invitation
• Start date: February 1, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: April 2024
• Source: Teleon Surgical B.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1000
• Est. completion date: April 30, 2024
• Est. primary completion date: January 31, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aphakia
• Cataract

Intervention

Device:
• Posterior-chamber intraocular lens
Implantation of a posterior-chamber intraocular lens to correct aphakia after removal of the crystalline lens

Locations

Country	Name	City	State
Netherlands	Teleon Surgical B.V.	Spankeren	AV

Sponsors (2)

Lead Sponsor	Collaborator
Teleon Surgical B.V.	MaganaMed GmbH

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adverse events and adverse device effects		Usual follow-up: 24 Months
Secondary	Patient and user satisfaction	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	Month 1