Bicentric Clinical Investigation to Assess Safety and Performance of LuxBoost IOL

Launched by CUTTING EDGE SAS · Feb 12, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at the safety and effectiveness of a new type of eye lens called LuxBoost when it is implanted in both eyes of people with cataracts. Cataracts are a common condition where the lens of the eye becomes cloudy, leading to vision problems. The study will compare the LuxBoost lens to another lens called LuxGood, which is already used for this purpose. The goal is to see how well the LuxBoost lens performs and if it is safe for patients.

To participate in this trial, you need to be at least 50 years old and have cataracts in both eyes, with surgery planned to replace the cloudy lenses with new ones. You should not have had any previous eye surgery or certain eye conditions that could affect the results of the study. If you join the trial, you will be asked to attend several follow-up appointments to monitor your progress. Participants will need to provide informed consent, meaning you’ll understand the study and agree to take part. This trial is currently recruiting participants of any gender, and it aims to help improve future cataract treatments.

Gender

ALL

Eligibility criteria

• 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