AphakiaLuxBoostNCT06258707
Bicentric Clinical Investigation to Assess Safety and Performance of LuxBoost IOL
A study testing LuxBoost IOL and LuxGood IOL in people with Aphakia, run by Cutting Edge SAS at 2 sites in France.
Trial summary
The study purpose is to demonstrate safety and performance of bilateral implantation of LuxBoost intraocular lenses compared with the LuxGood Monofocal lens. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Aphakia
- What is being tested?
- LuxBoost IOL and LuxGood IOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 2 sitesFrance
- Study dates
- 14 Oct 2024to 15 Jun 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject aged 50 or over on the day of inclusion, presenting a
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Clinique Honore Cave
Montauban, 82000
Vincent GUALINO, Dr
- Recruiting
West Ophta
Rennes, 35000
Pierre-Emmanuel ARCADE, Dr
About this study
Official title: Bicentric Clinical Investigation to Assess Safety and Performance of a Hydrophobic Acrylic Enhanced Monofocal Intraocular Lens.
The study purpose is to demonstrate safety and performance of bilateral implantation of LuxBoost intraocular lenses compared with the LuxGood Monofocal lens.
Read the detailed description
The study purpose is to demonstrate safety and performance after bilateral implantation of LuxBoost intraocular lenses.
The device under investigation is a hydrophobic acrylic monofocal intraocular lens (IOL) manufactured by the sponsor of this study.
- Conditions
- Aphakia
- Being tested
- LuxBoost IOL, LuxGood IOL
- Keywords
- Enhanced monofocal IOL
- Medical subject headings
- Aphakia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LuxBoost IOLDevice
Bilateral implantation in the capsular bag to replace the cataractous human crystalline lens.
LuxGood IOLDevice
Bilateral implantation in the capsular bag to replace the cataractous human crystalline lens.
| Study group | Role | What they receive |
|---|---|---|
| LuxBoost Group | Experimental | the experimental group will receive the LuxBoost intraocular lens. Receives: Device: LuxBoost IOL |
| LuxGood group | Active comparator | the control group will receive the LuxGood parent intraocular lens. Receives: Device: LuxGood IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Photopic visual acuity at far, intermediate and near distance in monocular and binocular with LuxBoost lens compared to LuxGood lens.
Measured: 4/6 months after surgery
Defocus curve
Binocular defocus curve with the distance correction
Measured: 4/6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start14 Oct 2024
- Primary completion15 Dec 2027 (estimated)
- Study completion15 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphakiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cutting Edge SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vincent GUALINO, Principal investigator, Clinique Honoré Cave 82000 MontaubanChristophe CESSES, Study director, Cutting Edge S.A.S (Sponsor)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06258707
- Sponsor's protocol ID
- CE2302
- Other IDs
- 2023-A02342-43
- Acronym
- LuxBoost
- Status last verified
- Aug 2026
- First submitted
- 1 Feb 2024
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No