Bicentric Clinical Investigation to Assess Safety and Performance of LuxBoost IOL
LuxBoost
2 other identifiers
interventional
58
1 country
2
Brief Summary
The study purpose is to demonstrate safety and performance of bilateral implantation of LuxBoost intraocular lenses compared with the LuxGood Monofocal lens.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2024
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2024
CompletedFirst Posted
Study publicly available on registry
February 14, 2024
CompletedStudy Start
First participant enrolled
October 14, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 15, 2027
February 12, 2026
February 1, 2026
2.2 years
February 1, 2024
February 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Best corrected distance visual acuity (CDVA)
To demonstrate the non-inferiority of LuxBoost IOL compared with the LuxGood monofocal control lens in terms of best corrected distance visual acuity (CDVA) by means of statistical significance.
4/6 months after surgery
Secondary Outcomes (2)
Uncorrected Distance Visual Acuity (UDVA), Uncorrected Intermediate Visual Acuity (UIVA), Distance Corrected Intermediate Visual Acuity (DCIVA), Uncorrected Near Visual Acuity (UNVA), Distance Corrected Near Visual Acuity (DCNVA)
4/6 months after surgery
Defocus curve
4/6 months after surgery
Other Outcomes (1)
Patient-reported outcomes
at preoperative visit and 4/6 months after surgery
Study Arms (2)
LuxBoost Group
EXPERIMENTALthe experimental group will receive the LuxBoost intraocular lens.
LuxGood group
ACTIVE COMPARATORthe control group will receive the LuxGood parent intraocular lens.
Interventions
Bilateral implantation in the capsular bag to replace the cataractous human crystalline lens.
Bilateral implantation in the capsular bag to replace the cataractous human crystalline lens.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Ocular surface disease potentially affecting study results
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cutting Edge SASlead
Study Sites (2)
Clinique Honore Cave
Montauban, 82000, France
West Ophta
Rennes, 35000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vincent GUALINO
Clinique Honoré Cave 82000 Montauban
- STUDY DIRECTOR
Christophe CESSES
Cutting Edge S.A.S (Sponsor)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2024
First Posted
February 14, 2024
Study Start
October 14, 2024
Primary Completion (Estimated)
December 15, 2026
Study Completion (Estimated)
June 15, 2027
Last Updated
February 12, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share