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| Name | Class |
|---|---|
| AST Products, Inc. | INDUSTRY |
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This is an observational, single-center, non-control, open-label post-marketing study. Patients implanted with an aspicioâ„¢ Monofocal Intraocular Lens will be scheduled for a follow-up visit at least 3 months after the surgery to undergo a routine basic ophthalmological examination.
This is an observational, single-center, non-control, open-label post-marketing study. Patients implanted with an aspicioâ„¢ Monofocal Intraocular Lens will be scheduled for a single visit in the facilities of Chang Gung University Hospital at least 3 months after the surgery. Patients will undergo a routine basic ophthalmological examination.
Additionally, and retrospectively, the patients' medical records will be reviewed to obtain information on visual acuity and adverse events at postoperative visit carried out 1 month after surgery.
The data corresponding to the preoperative values of corneal curvature (flat meridian, curved meridian and axes), axial length measured by biometry, visual acuity and those corresponding to the implanted IOL will also be collected from the medical records.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| aspicio Monofocal IOL | A bi-aspheric monofocal IOL is implanted through preloaded IOL Delivery System in the capsular bag in the posterior chamber of the eye during cataract surgery |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aspicio Monofocal IOL | Device | A bi-aspheric monofocal IOL is implanted through preloaded IOL Delivery System in the capsular bag in the posterior chamber of the eye during cataract surgery |
| Measure | Description | Time Frame |
|---|---|---|
| CDVA | Photopic monocular best corrected distance visual acuity (CDVA), 400cm | 3 months after implantation |
| Defocus curve | Photopic monocular defocus curve, -4.0 D ~ +2.0 D | 3 months after implantation |
| Measure | Description | Time Frame |
|---|---|---|
| UDVA | Photopic monocular uncorrected distance visual acuity (UDVA), 400cm | 3 months after implantation |
| UIVA | Photopic monocular uncorrected intermediate visual acuity (UIVA), 60cm |
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Inclusion Criteria:
Exclusion Criteria:
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Male or female adult patients who have been implanted with aspicioâ„¢ monofocal intraocular lens in at least 1 eye
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| Name | Affiliation | Role |
|---|---|---|
| Yih-Shiou Hwang, MD | Chang Gung University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung University Hospital | Taoyuan | Guishan District | 333 | Taiwan |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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|
| 3 months after implantation |
| CIVA | Photopic monocular corrected intermediate visual acuity (CIVA), 60cm | 3 months after implantation |
| IOL glistening | IOL glistening observation | 3 months after implantation |
| PCO | Posterior Capsular Opacification observation | 3 months after implantation |
| Satisfaction questionnaire | Satisfaction questionnaire | 3 months after implantation |
| AE | Signs of inflammation and AEs | 3 months after implantation |