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Prospective controlled monocentric study to determine the non-inferiority of the distance-corrected intermediate visual acuity at 66 cm of the SYNTHESIS PLUS TORIC with respect to the SYNTHESIS PLUS IOL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test device (Synthesis Plus Toric) | Requiring bilateral cataract surgery with pre-existing astigmatism |
| |
| Control device (Synthesis Plus) | Requiring bilateral cataract surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantation of Synthesis Plus IOL (control device) | Device | Synthesis Plus IOLs are indicated for primary implantation for the visual correction of aphakia in adult patients. |
|
| Measure | Description | Time Frame |
|---|---|---|
| DCIVA at 66 cm | The primary objective of this study is to determine the non-inferiority of the distance-corrected intermediate visual acuity at 66 cm of the SYNTHESIS PLUS TORIC with respect to the SYNTHESIS PLUS | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Monocular UDVA | distance | 1 month |
| Monocular BCDVA | distance | 1 month |
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Inclusion Criteria:
Non inclusion Criteria:
Exclusion criteria:
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Patient requiring bilateral cataract surgery
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Line Bettinelli, OD | Contact | 0619530701 | line.bettinelli@cutting-edge.fr |
| Name | Affiliation | Role |
|---|---|---|
| Boris Dethinne, MD | Visis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VISIS | Recruiting | Perpignan | 66000 | France |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| Implantation of Synthesis Plus Toric IOL (investigational device) | Device | Synthesis Plus Toric IOLs are indicated for primary implantation for the visual correction of aphakia in adult patients with pre-existing astigmatism. |
|
| Monocular UIVA |
66 cm |
| 1 month |
| Monocular DCIVA | 66 cm | 1 month |
| Refraction | subjective | 1 month |
| Potential complications | postoperative | 1 month |
| Rotational stability | in degrees | Peroperatively, day 0, Month 1 |
| Subjective quality of vision | PROM | 1 month |