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

Teleon Surgical B.V.2,183 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

2,183

Conditions

Aphakia Cataract Clear Lens Exchange Refractive Lens Exchange

Interventions

Posterior-chamber intraocular lensDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Teleon Surgical B.V.

Spankeren, AV, Netherlands

Outcomes

Primary Outcomes

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

Time frame: Preoperatively to Month 24

Secondary Outcomes

Adverse events and adverse device effects

Time frame: Usual follow-up: 24 Months

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

Time frame: Month 1

Data from ClinicalTrials.gov

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