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| Name | Class |
|---|---|
| MaganaMed GmbH | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects implanted with hydrophilic acrylic IOLs | Subjects were implanted with a HydroSmart IOL (FEMTIS, LENTIS or VISIOTIS) |
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| Subjects implanted with hydrophobic acrylic IOLs | Subjects were implanted with an ACUNEX IOL |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Posterior-chamber intraocular lens | Device | Implantation of a posterior-chamber intraocular lens to correct aphakia after removal of the crystalline lens |
|
| 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:
For multifocal IOLs:
For multifocal toric IOLs:
| Preoperatively to Month 24 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who have undergone uni- or bilateral extraction of the crystalline lens by means of phacoemulsification or femtosecond laser-assisted cataract surgery with implantation of the subject IOL.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teleon Surgical B.V. | Spankeren | AV | 6956 | Netherlands |
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| ID | Term |
|---|---|
| D001035 | Aphakia |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| Month 1 |