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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A02342-43 | Registry Identifier | French BRC Identification number |
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The study purpose is to demonstrate safety and performance of bilateral implantation of LuxBoost intraocular lenses compared with the LuxGood Monofocal lens.
The study purpose is to demonstrate safety and performance after bilateral implantation of LuxBoost intraocular lenses.
The device under investigation is a hydrophobic acrylic monofocal intraocular lens (IOL) manufactured by the sponsor of this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LuxBoost Group | Experimental | the experimental group will receive the LuxBoost intraocular lens. |
|
| LuxGood group | Active Comparator | the control group will receive the LuxGood parent intraocular lens. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LuxBoost IOL | Device | Bilateral implantation in the capsular bag to replace the cataractous human crystalline lens. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Best corrected distance visual acuity (CDVA) | To demonstrate the non-inferiority of LuxBoost IOL compared with the LuxGood monofocal control lens in terms of best corrected distance visual acuity (CDVA) by means of statistical significance. | 4/6 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Uncorrected Distance Visual Acuity (UDVA), Uncorrected Intermediate Visual Acuity (UIVA), Distance Corrected Intermediate Visual Acuity (DCIVA), Uncorrected Near Visual Acuity (UNVA), Distance Corrected Near Visual Acuity (DCNVA) | Photopic visual acuity at far, intermediate and near distance in monocular and binocular with LuxBoost lens compared to LuxGood lens. | 4/6 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported outcomes | Patient satisfaction using Catquest-9SF questionnaire : To assess if difficulties in daily life occur due to impaired sight. This questionnaire is a 9-item Rasch-scaled instrument to assess subjective perception of visual impairment after surgery [Lundström et al, 2009]. The acceptable values are > 3.00 for differentiation between low, medium, and high abilities. Rasch analysis is commonly reported as the mean of square residual (MNSQ) and z-standardized score (ZSTD). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ilham XHAARD | Contact | 620 050 651 | +33 | ilham.xhaard@cutting-edge.fr |
| Line BETTINELLI | Contact | 619 530 701 | +33 | line.bettinelli@cutting-edge.fr |
| Name | Affiliation | Role |
|---|---|---|
| Vincent GUALINO | Clinique Honoré Cave 82000 Montauban | Principal Investigator |
| Christophe CESSES | Cutting Edge S.A.S (Sponsor) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Honore Cave | Recruiting | Montauban | 82000 | France |
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| ID | Term |
|---|---|
| D001035 | Aphakia |
| 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. |
|
| Defocus curve | Binocular defocus curve with the distance correction | 4/6 months after surgery |
| at preoperative visit and 4/6 months after surgery |
| West Ophta | Recruiting | Rennes | 35000 | France |
|