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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A01904-41 | Registry Identifier | French BRC Identification number |
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The study purpose is to demonstrate safety and performance of bilateral implantation of LuxHighAdd intraocular lens compared with the LuxGood Monofocal lens.
The study purpose is to demonstrate safety and performance after bilateral implantation of LuxHighAdd intraocular lenses.
The device under investigation is a hydrophobic acrylic multifocal intraocular lens (IOL) manufactured by the sponsor of this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LuxHighAdd | Experimental | The experimental group will recieve the LuxHighAdd intraocular lens bilaterally. |
|
| LuxGood group | Active Comparator | The control group will recieve the LuxGood intraocular lens bilaterally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LuxHighAdd IOL | Device | Bilateral implantation in the capsular bag to replace the cataractous human crystalline lens. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Distance Corrected Near Visual Acuity (DCNVA) | To demonstrate the difference in monocular DCNVA between the High Add lens and the LuxGood monofocal lens by means of statistical significance. | 4/6 months after surgery |
| Best corrected distance visual acuity (BCDVA) | To demonstrate the non-inferiority of the Lux High Add lens compared with the monofocal control LuxGood lens in terms of BCDVA by means of statistical significance. | 4/6 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Uncorrected Distance Visual Acuity (UDVA) | Uncorrected photopic visual acuity at far in monocular and binocular with LuxHighAdd lens compared to LuxGood lens. | 4/6 months after surgery |
| Uncorrected Intermediate Visual Acuity (UIVA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Line Bettinelli, OD | Contact | 0619530701 | line.bettinelli@bausch.com | |
| Christophe Cesses | Contact | 0786991458 | christophe.cesses@bausch.com |
| Name | Affiliation | Role |
|---|---|---|
| Alain Saad, MD | Hôpital Fondation Adolphe de Rothschild | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre d'Ophtalmologie des Dr Rozot et associés | Recruiting | Marseille | 13008 | France |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| LuxGood IOL | Device | Bilateral implantation in the capsular bag to replace the cataractous human crystalline lens. |
|
Uncorrected photopic visual acuity at intermediate distance in monocular and binocular with LuxHighAdd lens compared to LuxGood lens.
| 4/6 months after surgery |
| Uncorrected Near Visual Acuity (UNVA) | Uncorrected photopic visual acuity at near distance in monocular and binocular with LuxHighAdd lens compared to LuxGood lens. | 4/6 months after surgery |
| Distance Corrected Intermediate Visual Acuity (DCIVA) | Photopic visual acuity at intermediate distance in monocular and binocular with best distance correction with LuxHighAdd lens compared to LuxGood lens. | 4/6 months after surgery |
| Manifest Refraction | Manifest subjective refraction | 4/6 months after surgery |
| Defocus curve | Binocular defocus curve with the distance correction | 4/6 months after surgery |
| Adverse events rates | Adverse events rates | 4/6 months after surgery |
| Contrast Sensitivity | Contrast Sensitivity in binocular conditions with distance correction | 4/6 months after surgery |
| Halo and glare scores | Halos and glare assessed with a simulator | 4/6 months after surgery |
| Patient-reported outcomes: Quality of vision Questionnaire | Assessment of quality of vision (CatQuest-9SF) | 4/6 months after surgery |
| Patient-reported outcomes: Spectacle independance Questionnaire | Assessment of spectacle independence (PRSIQ questionnaire ) | 4/6 months after surgery |
| Patient-reported outcomes: open-ended question | Frequency and proportion of eyes with ocular and visual symptoms (non-directed complaints) using an open-ended question | 4/6 months after surgery |
| Clinique Honoré Cave | Recruiting | Montauban | 82000 | France |
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| Hôpital Fondation Adolphe de Rothschild | Recruiting | Paris | 75019 | France |
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