Bicentric Clinical Investigation to Assess Safety and Performance of LuxBoost IOL
NCT ID: NCT06258707
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
58 participants
INTERVENTIONAL
2024-10-14
2026-12-15
Brief Summary
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Detailed Description
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The device under investigation is a hydrophobic acrylic monofocal intraocular lens (IOL) manufactured by the sponsor of this study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LuxBoost Group
the experimental group will receive the LuxBoost intraocular lens.
LuxBoost IOL
Bilateral implantation in the capsular bag to replace the cataractous human crystalline lens.
LuxGood group
the control group will receive the LuxGood parent intraocular lens.
LuxGood IOL
Bilateral implantation in the capsular bag to replace the cataractous human crystalline lens.
Interventions
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LuxBoost 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
* bilateral cataract for which posterior chamber IOL implantation
* has been planned.
* Fit within the available IOL diopter range.
* Have had no previous refractive surgery.
* Regular corneal astigmatism \< 1 dioptre by an automatic
* keratometer (regularity measured by topographer).
* Availability, willingness, and sufficient cognitive awareness to
* comply with examination procedures.
* Ability to attend all study follow-ups.
* Signed informed consent.
Exclusion Criteria
* 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
* Axial lengths and keratometry such as the IOL spherical power is
* not in the range of 14 to 28 D
* Instability of keratometry or biometry measurements
* 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
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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Vincent GUALINO
Role: PRINCIPAL_INVESTIGATOR
Clinique Honoré Cave 82000 Montauban
Christophe CESSES
Role: STUDY_DIRECTOR
Cutting Edge S.A.S (Sponsor)
Locations
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Clinique Honore Cave
Montauban, , France
West Optha
Rennes, , France
Countries
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Central Contacts
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Other Identifiers
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2023-A02342-43
Identifier Type: REGISTRY
Identifier Source: secondary_id
CE2302
Identifier Type: -
Identifier Source: org_study_id
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