Multicentric Clinical Investigation to Determine Safety and Efficacy of a Hydrophobic Acrylic Multifocal Intraocular Lens
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Cutting Edge SAS
- Enrollment
- 57
- Locations
- 5
- Primary Endpoint
- Distance Corrected Near Visual Acuity (DCNVA)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
LuxHighAdd
The experimental group will recieve the LuxHighAdd intraocular lens bilaterally.
Intervention: LuxHighAdd IOL (Device)
LuxGood group
The control group will recieve the LuxGood intraocular lens bilaterally.
Intervention: LuxGood IOL (Device)
Outcomes
Primary Outcomes
Distance Corrected Near Visual Acuity (DCNVA)
Time Frame: 4/6 months after surgery
To demonstrate the difference in monocular DCNVA between the High Add lens and the LuxGood monofocal lens by means of statistical significance.
Best corrected distance visual acuity (BCDVA)
Time Frame: 4/6 months after surgery
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.
Secondary Outcomes
- Manifest Refraction(4/6 months after surgery)
- Defocus curve(4/6 months after surgery)
- Adverse events rates(4/6 months after surgery)
- Uncorrected Distance Visual Acuity (UDVA)(4/6 months after surgery)
- Uncorrected Near Visual Acuity (UNVA)(4/6 months after surgery)
- Contrast Sensitivity(4/6 months after surgery)
- Patient-reported outcomes: Quality of vision Questionnaire(4/6 months after surgery)
- Patient-reported outcomes: open-ended question(4/6 months after surgery)
- Uncorrected Intermediate Visual Acuity (UIVA)(4/6 months after surgery)
- Distance Corrected Intermediate Visual Acuity (DCIVA)(4/6 months after surgery)
- Halo and glare scores(4/6 months after surgery)
- Patient-reported outcomes: Spectacle independance Questionnaire(4/6 months after surgery)