An interventional study of LuxBoost IOL and LuxGood IOL in Aphakia, sponsored by Cutting Edge SAS. Recruiting at 2 sites in France. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Cutting Edge SAS · Not applicable, Interventional, and Treatment
The study purpose is to demonstrate safety and performance of bilateral implantation of LuxBoost intraocular lenses compared with the LuxGood Monofocal lens.
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.
69 studies on the registry are indexed under Aphakia; 6 are open to participants now.
This study's planned enrollment of 58 is below the median of 103 across 52 interventional studies indexed under Aphakia.
Browse Aphakia studies →Cutting Edge SAS is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
the experimental group will receive the LuxBoost intraocular lens.
Device: LuxBoost IOL
the control group will receive the LuxGood parent intraocular lens.
Device: LuxGood IOL
Bilateral implantation in the capsular bag to replace the cataractous human crystalline lens.
Bilateral implantation in the capsular bag to replace the cataractous human crystalline lens.
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.
Time frame: 4/6 months after surgery
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.
Time frame: 4/6 months after surgery
Defocus curve
Binocular defocus curve with the distance correction
Time frame: 4/6 months after surgery
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).
Time frame: at preoperative visit and 4/6 months after surgery
Plan to share: No
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Cutting Edge SAS