Aphakia Clinical Trial
— LuxBoostOfficial title:
Bicentric Clinical Investigation to Assess Safety and Performance of a Hydrophobic Acrylic Enhanced Monofocal Intraocular Lens.
The study purpose is to demonstrate safety and performance of bilateral implantation of LuxBoost intraocular lenses compared with the LuxGood Monofocal lens.
Status | Not yet recruiting |
Enrollment | 58 |
Est. completion date | January 15, 2026 |
Est. primary completion date | August 15, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility | 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Cutting Edge SAS |
Type | Measure | Description | Time frame | Safety issue |
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Other | 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). | at preoperative visit and 4/6 months after surgery | |
Primary | 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 | |
Secondary | 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 | |
Secondary | Defocus curve | Binocular defocus curve with the distance correction | 4/6 months after surgery |
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