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

Study Overview
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Brief Summary
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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.

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

Conditions
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Aphakia, Cataract, Clear Lens Exchange, Refractive Lens Exchange

Intervention / Treatment
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* Device: Posterior-chamber intraocular lens


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects implanted with hydrophilic acrylic IOLs<br>Subjects were implanted with a HydroSmart IOL (FEMTIS, LENTIS or VISIOTIS) | Device: Posterior-chamber intraocular lens<br>* Implantation of a posterior-chamber intraocular lens to correct aphakia after removal of the crystalline lens<br>|
| Subjects implanted with hydrophobic acrylic IOLs<br>Subjects were implanted with an ACUNEX IOL | Device: Posterior-chamber intraocular lens<br>* Implantation of a posterior-chamber intraocular lens to correct aphakia after removal of the crystalline lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events and adverse device effects |  | 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 | Month 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pseudoaphakia