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| Name | Class |
|---|---|
| AST Products, Inc. | INDUSTRY |
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This is a study to evaluate the safety, effectiveness and patient satisfaction of the Trifocal Intraocular Lens after implanted to replace the natural lens following cataract removal.
This study is a single-arm unmasked clinical evaluation study of safety, effectiveness and patient satisfactions of the Trifocal Intraocular Lens after successful bilateral cataract surgery. Subjects will be assessed pre-operative, operative date and at 1-2 days, 1-2 weeks, 1-2 months, 3-4 months and 6 months post-operative. Clinical evaluations will include probability of adverse events, patient satisfaction questionnaire, as well as measurements of monocular and bilateral far, intermediate and near visual acuity as a result of Trifocal Lens performance, etc.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trifocal Preloaded IOL Delivery System | Experimental | Bilateral trifocal IOLs implanted through preloaded IOL Delivery System in the capsular bag in the posterior chamber of the eye during cataract surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trifocal Preloaded IOL Delivery System | Device | UV and blue-light filtering foldable trifocal IOL with a +2.2 diopter (D) addition power of intermediate visual acuity and a +3.3 D addition power of near visual acuity. This device is approved in Taiwan. |
| Measure | Description | Time Frame |
|---|---|---|
| Photopic monocular CDVA, 400 cm | 6 Months post second eye implantation | |
| Photopic monocular CIVA, 60 cm | 6 Months post second eye implantation | |
| Photopic monocular CNVA, 40 cm | 6 Months post second eye implantation | |
| Rates of adverse events vs. ISO 11979-7:2018 SPE rate | 6 Months post second eye implantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yih-Shiou Hwang, Dr. | Chang Gung Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital, Linkou | Taoyuan | Taiwan |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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