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Recruiting NCT06446817

Multicentric Clinical Investigation to Assess Safety and Performance of Lux HighAdd IOL

No phase Interventional Cataract

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LuxHighAdd IOL, LuxGood IOL.
Who it may be relevant to
Registry conditions: Cataract. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Multicentric Clinical Investigation to Determine Safety and Efficacy of a Hydrophobic Acrylic Multifocal Intraocular Lens

Overview

The study purpose is to demonstrate safety and performance of bilateral implantation of LuxHighAdd intraocular lens compared with the LuxGood Monofocal lens.

Detailed description

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.

Interventions

  • Device LuxHighAdd IOL
    Bilateral implantation in the capsular bag to replace the cataractous human crystalline lens.
  • Device LuxGood IOL
    Bilateral implantation in the capsular bag to replace the cataractous human crystalline lens.

Primary outcome measures

  • Distance Corrected Near Visual Acuity (DCNVA) [Time frame: 4/6 months after surgery]
  • Best corrected distance visual acuity (BCDVA) [Time frame: 4/6 months after surgery]
Secondary outcome measures (12)
  • Uncorrected Distance Visual Acuity (UDVA) [Time frame: 4/6 months after surgery]
  • Uncorrected Intermediate Visual Acuity (UIVA) [Time frame: 4/6 months after surgery]
  • Uncorrected Near Visual Acuity (UNVA) [Time frame: 4/6 months after surgery]
  • Distance Corrected Intermediate Visual Acuity (DCIVA) [Time frame: 4/6 months after surgery]
  • Manifest Refraction [Time frame: 4/6 months after surgery]
  • Defocus curve [Time frame: 4/6 months after surgery]
  • Adverse events rates [Time frame: 4/6 months after surgery]
  • Contrast Sensitivity [Time frame: 4/6 months after surgery]
  • Halo and glare scores [Time frame: 4/6 months after surgery]
  • Patient-reported outcomes: Quality of vision Questionnaire [Time frame: 4/6 months after surgery]
  • Patient-reported outcomes: Spectacle independance Questionnaire [Time frame: 4/6 months after surgery]
  • Patient-reported outcomes: open-ended question [Time frame: 4/6 months after surgery]

Eligibility criteria

Inclusion criteria

  • 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
  • Regular corneal astigmatism ≤1.0 dioptres
  • Clear intraocular media other than cataract
  • Availability, willingness and sufficient cognitive awareness to comply with examination procedures
  • Ability to attend all study follow-ups
  • Signed informed consent.

Exclusion criteria

  • 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)
  • Axial lengths and keratometry such as the IOL spherical power is not in the range of 16 to 26 D
  • Instability of keratometry or biometry measurements
  • Traumatic cataract
  • Amblyopia
  • History of ocular trauma or any prior ocular surgery including refractive procedures
  • Capsular or zonular abnormalities that may affect postoperative centration or tilt of the lens
  • Pupil abnormalities
  • Systemic or ocular medication that could modify pupil dynamics
  • Expected complicated surgery or complicated surgery
  • Concurrent participation in another drug or device investigation

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

France · 3 centers
  • Centre d'Ophtalmologie des Dr Rozot et associés — Marseille
  • Clinique Honoré Cave — Montauban
  • Hôpital Fondation Adolphe de Rothschild — Paris

Identifiers

NCT: NCT06446817 · CE2301 · 2023-A01904-41

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗