Multicentric Clinical Investigation to Assess Safety and Performance of Lux HighAdd IOL
ConditionCataract
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 LuxHighAdd intraocular lens 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, qualified for bilateral implantation
No ocular comorbidity possibly affecting the study results
Fit within the available IOL diopter range
Have had no previous refractive surgery
Disqualifiers
Ocular surface disease potentially affecting study results
Pre-existing ocular pathology or history of pathology potentially affecting the study results
Acute or chronic disease or illness that would increase risk or confound study results
Subjects who may be reasonably expected to require a secondary surgical intervention at any time during the investigation (other than YAG capsulotomy)
Trial design
Design model
Parallel
Treatments tested in this trial
LuxHighAdd 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
57 Participants
are divided into 2 treatment groupsGroup A: LuxHighAddExperimental treatment 1 intervention
Group B: LuxGood groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Distance 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 surgery2
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 surgerySecondary outcomes
1
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 surgery2
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 surgery3
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 surgery4
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 surgerySponsors and contacts
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Source ClinicalTrials.gov