Bicentric Clinical Investigation to Assess Safety and Performance of LuxHighAdd IOL
NCT ID: NCT06446817
Last Updated: 2025-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
57 participants
INTERVENTIONAL
2024-12-19
2026-07-01
Brief Summary
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Detailed Description
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The device under investigation is a hydrophobic acrylic multifocal intraocular lens (IOL) manufactured by the sponsor of this study.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LuxHighAdd
The experimental group will recieve the LuxHighAdd intraocular lens bilaterally.
LuxHighAdd IOL
Bilateral implantation in the capsular bag to replace the cataractous human crystalline lens.
LuxGood group
The control group will recieve the LuxGood intraocular lens bilaterally.
LuxGood IOL
Bilateral implantation in the capsular bag to replace the cataractous human crystalline lens.
Interventions
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LuxHighAdd IOL
Bilateral implantation in the capsular bag to replace the cataractous human crystalline lens.
LuxGood IOL
Bilateral implantation in the capsular bag to replace the cataractous human crystalline lens.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
ALL
No
Sponsors
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Cutting Edge SAS
INDUSTRY
Responsible Party
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Principal Investigators
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Alain Saad, MD
Role: PRINCIPAL_INVESTIGATOR
Hôpital Fondation Adolphe de Rothschild
Locations
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Hôpital Fondation Adolphe de Rothschild
Paris, , France
WestOphta
Rennes, , France
Countries
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Central Contacts
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Facility Contacts
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Alain Saad, MD
Role: primary
Pierre-Emmanuel Arcade, MD
Role: primary
Other Identifiers
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2023-A01904-41
Identifier Type: REGISTRY
Identifier Source: secondary_id
CE2301
Identifier Type: -
Identifier Source: org_study_id
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