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RecruitingNCT06446817HIGHADDUpdated May 26, 2026

Multicentric Clinical Investigation to Assess Safety and Performance of Lux HighAdd IOL

An interventional study of LuxHighAdd IOL and LuxGood IOL in Cataract, sponsored by Cutting Edge SAS. Recruiting at 3 sites in France. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-05-26.

Sponsored by Cutting Edge SAS · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2024; still recruiting 1 year 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
57
Allocation
Non-randomized
Ages
50 Years and older
Sex
All
01

Study summary

The study purpose is to demonstrate safety and performance of bilateral implantation of LuxHighAdd intraocular lens compared with the LuxGood Monofocal lens.

Read the 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.

02

Conditions studied

  • Cataract

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03

In context

Cataract

1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.

This study's planned enrollment of 57 is below the median of 79 across 1,092 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Cutting Edge SAS is the lead sponsor of 5 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
57 participants (estimated)

Study arms

  • Experimental
    LuxHighAdd

    The experimental group will recieve the LuxHighAdd intraocular lens bilaterally.

    Device: LuxHighAdd IOL

  • Active comparator
    LuxGood group

    The control group will recieve the LuxGood intraocular lens bilaterally.

    Device: LuxGood IOL

Interventions

  • DeviceLuxHighAdd IOL

    Bilateral implantation in the capsular bag to replace the cataractous human crystalline lens.

  • DeviceLuxGood IOL

    Bilateral implantation in the capsular bag to replace the cataractous human crystalline lens.

06

What researchers measure

Primary outcomes

  1. Distance Corrected Near Visual Acuity (DCNVA)

    To demonstrate the difference in monocular DCNVA between the High Add lens and the LuxGood monofocal lens by means of statistical significance.

    Time frame: 4/6 months after surgery

  2. Best corrected distance visual acuity (BCDVA)

    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.

    Time frame: 4/6 months after surgery

Secondary outcomes

  1. Uncorrected Distance Visual Acuity (UDVA)

    Uncorrected photopic visual acuity at far in monocular and binocular with LuxHighAdd lens compared to LuxGood lens.

    Time frame: 4/6 months after surgery

  2. Uncorrected Intermediate Visual Acuity (UIVA)

    Uncorrected photopic visual acuity at intermediate distance in monocular and binocular with LuxHighAdd lens compared to LuxGood lens.

    Time frame: 4/6 months after surgery

  3. Uncorrected Near Visual Acuity (UNVA)

    Uncorrected photopic visual acuity at near distance in monocular and binocular with LuxHighAdd lens compared to LuxGood lens.

    Time frame: 4/6 months after surgery

  4. Distance Corrected Intermediate Visual Acuity (DCIVA)

    Photopic visual acuity at intermediate distance in monocular and binocular with best distance correction with LuxHighAdd lens compared to LuxGood lens.

    Time frame: 4/6 months after surgery

  5. Manifest Refraction

    Manifest subjective refraction

    Time frame: 4/6 months after surgery

  6. Defocus curve

    Binocular defocus curve with the distance correction

    Time frame: 4/6 months after surgery

  7. Adverse events rates

    Adverse events rates

    Time frame: 4/6 months after surgery

  8. Contrast Sensitivity

    Contrast Sensitivity in binocular conditions with distance correction

    Time frame: 4/6 months after surgery

  9. Halo and glare scores

    Halos and glare assessed with a simulator

    Time frame: 4/6 months after surgery

  10. Patient-reported outcomes: Quality of vision Questionnaire

    Assessment of quality of vision (CatQuest-9SF)

    Time frame: 4/6 months after surgery

  11. Patient-reported outcomes: Spectacle independance Questionnaire

    Assessment of spectacle independence (PRSIQ questionnaire )

    Time frame: 4/6 months after surgery

  12. Patient-reported outcomes: open-ended question

    Frequency and proportion of eyes with ocular and visual symptoms (non-directed complaints) using an open-ended question

    Time frame: 4/6 months after surgery

07

Study locations

3 of 3 sites recruiting
  • Centre d'Ophtalmologie des Dr Rozot et associés
    Marseille, 13008, France
    Recruiting
    • Dr Rozot, MD · Contact+334 91 22 24 29
    • Pascal ROZOT, MD · Principal investigator
  • Clinique Honoré Cave
    Montauban, 82000, France
    Recruiting
  • Hôpital Fondation Adolphe de Rothschild
    Paris, 75019, France
    Recruiting
    • Alain Saad, MD · Contact
    • Alain Saad, MD · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2024 (actual). Primary completion is estimated for Sep 2028, 45 months after the start.

Of 190 industry-sponsored interventional studies with no phase under Cataract, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 28. This study's planned 45 months is above that.

Counting every sponsor, half of 490 studies reached it within 17 months; a quarter within 9 and three quarters within 28.

How these figures are worked out, and which studies are left out of them.

Registered
May 23, 2024
First posted
Jun 6, 2024
StartActual
Dec 19, 2024
Primary completionEst.
Sep 2028
CompletionEst.
Dec 2028
Last update
May 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06446817
Lead sponsor
Cutting Edge SAS
Responsible party
Sponsor
First posted
Jun 6, 2024
Start date
Dec 19, 2024
Primary completion
Sep 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
May 26, 2026

Study contacts

Line Bettinelli, OD
Contact
line.bettinelli@bausch.com
0619530701
Christophe Cesses
Contact
christophe.cesses@bausch.com
0786991458
Alain Saad, MD
principal investigator · Hôpital Fondation Adolphe de Rothschild

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Discussion

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