Aphakia
Conditions
Keywords
Enhanced monofocal IOL
Brief summary
The study purpose is to demonstrate safety and performance of bilateral implantation of LuxBoost intraocular lenses compared with the LuxGood Monofocal lens.
Detailed description
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.
Interventions
DEVICELuxBoost 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
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 for which posterior chamber IOL implantation * has been planned. * Fit within the available IOL diopter range. * Have had no previous refractive surgery. * Regular corneal astigmatism \< 1 dioptre by an automatic * keratometer (regularity measured by topographer). * 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 * Subjects suffering from diagnosed degenerative visual disorders * Pre-existing ocular pathology * Acute or chronic disease or illness that would increase risk or confound study results * Axial lengths and keratometry such as the IOL spherical power is * not in the range of 14 to 28 D * Instability of keratometry or biometry measurements * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Best corrected distance visual acuity (CDVA) | 4/6 months after surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 4/6 months after surgery | Photopic visual acuity at far, intermediate and near distance in monocular and binocular with LuxBoost lens compared to LuxGood lens. |
| Defocus curve | 4/6 months after surgery | Binocular defocus curve with the distance correction |
Countries
France
Contacts
CONTACTIlham XHAARD
CONTACTLine BETTINELLI
PRINCIPAL_INVESTIGATORVincent GUALINO
Clinique Honoré Cave 82000 Montauban
STUDY_DIRECTORChristophe CESSES
Cutting Edge S.A.S (Sponsor)
Outcome results
None listed