Registry Study on Intraocular Lenses Manufactured by Teleon Surgical B.V.
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Subjects implanted with hydrophilic acrylic IOLs Subjects were implanted with a HydroSmart IOL (FEMTIS, LENTIS or VISIOTIS) |
Device: Posterior-chamber intraocular lens
Implantation of a posterior-chamber intraocular lens to correct aphakia after removal of the crystalline lens
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Subjects implanted with hydrophobic acrylic IOLs Subjects were implanted with an ACUNEX IOL |
Device: Posterior-chamber intraocular lens
Implantation of a posterior-chamber intraocular lens to correct aphakia after removal of the crystalline lens
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients older than 18 years
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Diagnosis of cataract in at least one eye or seeking clear/refractive lens exchange
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Provide consent to retrospective data collection
Exclusion Criteria:
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Patients younger than 18 years
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Patients with congenital primary aphakia or secondary aphakia
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Teleon Surgical B.V. | Spankeren | AV | Netherlands | 6956 |
Sponsors and Collaborators
- Teleon Surgical B.V.
- medXteam GmbH
- MaganaMed GmbH
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PMCF-01-ACX-HS-2022