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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
58
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.
Clinique Honore Cave
Montauban, France
RECRUITINGWest Ophta
Rennes, France
RECRUITINGBest 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
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