Cataract
Conditions
Brief summary
The study purpose is to demonstrate safety and performance of bilateral implantation of LuxHighAdd intraocular lens compared with the LuxGood Monofocal lens.
Detailed description
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.
Interventions
DEVICELuxHighAdd IOL
Bilateral implantation in the capsular bag to replace the cataractous human crystalline lens.
DEVICELuxGood IOL
Bilateral implantation in the capsular bag to replace the cataractous human crystalline lens.
Sponsors
Cutting Edge SAS
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject aged 50 or over on the day of inclusion, presenting a bilateral cataract, qualified for bilateral implantation * No ocular comorbidity possibly affecting the study results * Fit within the available IOL diopter range * Have had no previous refractive surgery * Regular corneal astigmatism ≤1.0 dioptres * Clear intraocular media other than cataract * Availability, willingness and sufficient cognitive awareness to comply with examination procedures * Ability to attend all study follow-ups * Signed informed consent.
Exclusion criteria
* Ocular surface disease potentially affecting study results * Pre-existing ocular pathology or history of pathology potentially affecting the study results * Acute or chronic disease or illness that would increase risk or confound study results * Subjects who may be reasonably expected to require a secondary surgical intervention at any time during the investigation (other than YAG capsulotomy) * Axial lengths and keratometry such as the IOL spherical power is not in the range of 16 to 26 D * Instability of keratometry or biometry measurements * Traumatic cataract * Amblyopia * History of ocular trauma or any prior ocular surgery including refractive procedures * Capsular or zonular abnormalities that may affect postoperative centration or tilt of the lens * Pupil abnormalities * Systemic or ocular medication that could modify pupil dynamics * Expected complicated surgery or complicated surgery * Concurrent participation in another drug or device investigation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distance Corrected Near Visual Acuity (DCNVA) | 4/6 months after surgery | To demonstrate the difference in monocular DCNVA between the High Add lens and the LuxGood monofocal lens by means of statistical significance. |
| Best corrected distance visual acuity (BCDVA) | 4/6 months after surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Uncorrected Distance Visual Acuity (UDVA) | 4/6 months after surgery | Uncorrected photopic visual acuity at far in monocular and binocular with LuxHighAdd lens compared to LuxGood lens. |
| Uncorrected Intermediate Visual Acuity (UIVA) | 4/6 months after surgery | Uncorrected photopic visual acuity at intermediate distance in monocular and binocular with LuxHighAdd lens compared to LuxGood lens. |
| Uncorrected Near Visual Acuity (UNVA) | 4/6 months after surgery | Uncorrected photopic visual acuity at near distance in monocular and binocular with LuxHighAdd lens compared to LuxGood lens. |
| Distance Corrected Intermediate Visual Acuity (DCIVA) | 4/6 months after surgery | Photopic visual acuity at intermediate distance in monocular and binocular with best distance correction with LuxHighAdd lens compared to LuxGood lens. |
| Manifest Refraction | 4/6 months after surgery | Manifest subjective refraction |
| Defocus curve | 4/6 months after surgery | Binocular defocus curve with the distance correction |
| Adverse events rates | 4/6 months after surgery | Adverse events rates |
| Contrast Sensitivity | 4/6 months after surgery | Contrast Sensitivity in binocular conditions with distance correction |
| Halo and glare scores | 4/6 months after surgery | Halos and glare assessed with a simulator |
| Patient-reported outcomes: Quality of vision Questionnaire | 4/6 months after surgery | Assessment of quality of vision (CatQuest-9SF) |
| Patient-reported outcomes: Spectacle independance Questionnaire | 4/6 months after surgery | Assessment of spectacle independence (PRSIQ questionnaire ) |
| Patient-reported outcomes: open-ended question | 4/6 months after surgery | Frequency and proportion of eyes with ocular and visual symptoms (non-directed complaints) using an open-ended question |
Countries
France
Contacts
CONTACTLine Bettinelli, OD
CONTACTChristophe Cesses
PRINCIPAL_INVESTIGATORAlain Saad, MD
Hôpital Fondation Adolphe de Rothschild
Outcome results
None listed