Bicentric Clinical Investigation to Assess Safety and Performance of LuxBoost IOL
ConditionAphakia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorCutting Edge SAS
About this trial
The study purpose is to demonstrate safety and performance of bilateral implantation of LuxBoost intraocular lenses compared with the LuxGood Monofocal lens.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
LuxBoost IOL
DeviceBilateral implantation in the capsular bag to replace the cataractous human crystalline lens.
LuxGood IOL
DeviceBilateral implantation in the capsular bag to replace the cataractous human crystalline lens.
Treatment groups
58 Participants
are divided into 2 treatment groupsGroup A: LuxBoost GroupExperimental treatment 1 intervention
Group B: LuxGood groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 surgerySecondary outcomes
1
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 surgery2
Defocus curve
Binocular defocus curve with the distance correction
Time frame
4/6 months after surgeryOther outcomes
1
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 surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov