Bicentric Clinical Investigation to Assess Safety and Performance of LuxBoost IOL

Aphakia Clinical Trial

— LuxBoost  

Official title:

Bicentric Clinical Investigation to Assess Safety and Performance of a Hydrophobic Acrylic Enhanced Monofocal Intraocular Lens.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06258707
• Other study ID #: CE2302
• Secondary ID: 2023-A02342-43
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 15, 2024
• Est. completion date: January 15, 2026

Study information

• Verified date: February 2024
• Source: Cutting Edge SAS
• Contact: Ilham XHAARD
• Phone: 620 050 651
• Email: ilham.xhaard[@]cutting-edge.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study purpose is to demonstrate safety and performance of bilateral implantation of LuxBoost intraocular lenses compared with the LuxGood Monofocal lens.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Aphakia

Intervention

Device:
• LuxBoost IOL
Bilateral implantation in the capsular bag to replace the cataractous human crystalline lens.
• LuxGood IOL
Bilateral implantation in the capsular bag to replace the cataractous human crystalline lens.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cutting Edge SAS

Outcome

Type	Measure	Description	Time frame	Safety issue
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