The study purpose is to demonstrate safety and performance of bilateral implantation of LuxHighAdd intraocular lens compared with the LuxGood Monofocal lens.
The study purpose is to demonstrate safety and performance after bilateral implantation of LuxHighAdd intraocular lenses. The device under investigation is a hydrophobic acrylic multifocal intraocular lens (IOL) manufactured by the sponsor of this study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
57
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.
Hôpital Fondation Adolphe de Rothschild
Paris, France
RECRUITINGWestOphta
Rennes, France
RECRUITINGDistance Corrected Near Visual Acuity (DCNVA)
To demonstrate the difference in monocular DCNVA between the High Add lens and the LuxGood monofocal lens by means of statistical significance.
Time frame: 4/6 months after surgery
Best corrected distance visual acuity (BCDVA)
To demonstrate the non-inferiority of the Lux High Add lens compared with the monofocal control LuxGood lens in terms of BCDVA by means of statistical significance.
Time frame: 4/6 months after surgery
Uncorrected Distance Visual Acuity (UDVA)
Uncorrected photopic visual acuity at far in monocular and binocular with LuxHighAdd lens compared to LuxGood lens.
Time frame: 4/6 months after surgery
Uncorrected Intermediate Visual Acuity (UIVA)
Uncorrected photopic visual acuity at intermediate distance in monocular and binocular with LuxHighAdd lens compared to LuxGood lens.
Time frame: 4/6 months after surgery
Uncorrected Near Visual Acuity (UNVA)
Uncorrected photopic visual acuity at near distance in monocular and binocular with LuxHighAdd lens compared to LuxGood lens.
Time frame: 4/6 months after surgery
Distance Corrected Intermediate Visual Acuity (DCIVA)
Photopic visual acuity at intermediate distance in monocular and binocular with best distance correction with LuxHighAdd lens compared to LuxGood lens.
Time frame: 4/6 months after surgery
Manifest Refraction
Manifest subjective refraction
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Time frame: 4/6 months after surgery
Defocus curve
Binocular defocus curve with the distance correction
Time frame: 4/6 months after surgery
Adverse events rates
Adverse events rates
Time frame: 4/6 months after surgery
Contrast Sensitivity
Contrast Sensitivity in binocular conditions with distance correction
Time frame: 4/6 months after surgery
Halo and glare scores
Halos and glare assessed with a simulator
Time frame: 4/6 months after surgery
Patient-reported outcomes: Quality of vision Questionnaire
Assessment of quality of vision (CatQuest-9SF)
Time frame: 4/6 months after surgery
Patient-reported outcomes: Spectacle independance Questionnaire
Assessment of spectacle independence (PRSIQ questionnaire )
Time frame: 4/6 months after surgery
Patient-reported outcomes: open-ended question
Frequency and proportion of eyes with ocular and visual symptoms (non-directed complaints) using an open-ended question
Time frame: 4/6 months after surgery