CataractHIGHADDNCT06446817
Multicentric Clinical Investigation to Assess Safety and Performance of Lux HighAdd IOL
A study testing LuxHighAdd IOL and LuxGood IOL in people with Cataract, run by Cutting Edge SAS at 3 sites in France.
Trial summary
The study purpose is to demonstrate safety and performance of bilateral implantation of LuxHighAdd intraocular lens 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
- Cataract
- What is being tested?
- LuxHighAdd IOL and LuxGood IOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 3 sitesFrance
- Study dates
- 19 Dec 2024to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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, 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
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- 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
- 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
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- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
Centre d'Ophtalmologie des Dr Rozot et associés
Marseille, 13008
Dr Rozot, MD, +334 91 22 24 29
Pascal ROZOT, MD
- Recruiting
Clinique Honoré Cave
Montauban, 82000
Cloé Sanchez, +33563030304, cloe.sanchez@clinique-honore-cave.com
Vincent GUALINO, MD
- Recruiting
Hôpital Fondation Adolphe de Rothschild
Paris, 75019
Alain Saad, MD
Alain Saad, MD
About this study
Official title: Multicentric Clinical Investigation to Determine Safety and Efficacy of a Hydrophobic Acrylic Multifocal Intraocular Lens
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.
- Conditions
- Cataract
- Being tested
- LuxHighAdd IOL, LuxGood IOL
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LuxHighAdd 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 |
|---|---|---|
| LuxHighAdd | Experimental | The experimental group will recieve the LuxHighAdd intraocular lens bilaterally. Receives: Device: LuxHighAdd IOL |
| LuxGood group | Active comparator | The control group will recieve the LuxGood intraocular lens bilaterally. Receives: Device: LuxGood IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4/6 months after surgery
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.
Measured: 4/6 months after surgery
Secondary outcomes (12)
Uncorrected Distance Visual Acuity (UDVA)
Uncorrected photopic visual acuity at far in monocular and binocular with LuxHighAdd lens compared to LuxGood lens.
Measured: 4/6 months after surgery
Uncorrected Intermediate Visual Acuity (UIVA)
Uncorrected photopic visual acuity at intermediate distance in monocular and binocular with LuxHighAdd lens compared to LuxGood lens.
Measured: 4/6 months after surgery
Uncorrected Near Visual Acuity (UNVA)
Uncorrected photopic visual acuity at near distance in monocular and binocular with LuxHighAdd lens compared to LuxGood lens.
Measured: 4/6 months after surgery
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.
Measured: 4/6 months after surgery
Manifest Refraction
Manifest subjective refraction
Measured: 4/6 months after surgery
Defocus curve
Binocular defocus curve with the distance correction
Measured: 4/6 months after surgery
Adverse events rates
Adverse events rates
Measured: 4/6 months after surgery
Contrast Sensitivity
Contrast Sensitivity in binocular conditions with distance correction
Measured: 4/6 months after surgery
Halo and glare scores
Halos and glare assessed with a simulator
Measured: 4/6 months after surgery
Patient-reported outcomes: Quality of vision Questionnaire
Assessment of quality of vision (CatQuest-9SF)
Measured: 4/6 months after surgery
Patient-reported outcomes: Spectacle independance Questionnaire
Assessment of spectacle independence (PRSIQ questionnaire )
Measured: 4/6 months after surgery
Patient-reported outcomes: open-ended question
Frequency and proportion of eyes with ocular and visual symptoms (non-directed complaints) using an open-ended question
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 posted6 Jun 2024
- Study start19 Dec 2024
- Primary completionSep 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cutting Edge SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alain Saad, MD, Principal investigator, Hôpital Fondation Adolphe de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06446817
- Sponsor's protocol ID
- CE2301
- Other IDs
- 2023-A01904-41
- Acronym
- HIGHADD
- Status last verified
- May 2026
- First submitted
- 23 May 2024
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Clinical Investigation to Determine Safety and Efficacy of a Hydrophobic Acrylic Multifocal Intraocular Lens
- ClinicalTrials.gov ID
- NCT06446817
- Acronym / sponsor ID
- HIGHADD / CE2301
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Cutting Edge SASIndustry (pharma, biotech, devices)
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 6 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study purpose is to demonstrate safety and performance of bilateral implantation of LuxHighAdd intraocular lens compared with the LuxGood Monofocal lens.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LuxHighAdd | Experimental | Device: LuxHighAdd IOLThe experimental group will recieve the LuxHighAdd intraocular lens bilaterally. |
| LuxGood group | Active comparator | Device: LuxGood IOLThe control group will recieve the LuxGood intraocular lens bilaterally. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LuxHighAdd IOLBilateral implantation in the capsular bag to replace the cataractous human crystalline lens. | Device | LuxHighAdd |
| LuxGood IOLBilateral implantation in the capsular bag to replace the cataractous human crystalline lens. | Device | LuxGood group |
Primary outcome
Distance Corrected Near Visual Acuity (DCNVA)
Time frame: 4/6 months after surgery
To demonstrate the difference in monocular DCNVA between the High Add lens and the LuxGood monofocal lens by means of statistical significance.
Best corrected distance visual acuity (BCDVA)
Time frame: 4/6 months after surgery
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.
12 secondary outcomes
Uncorrected Distance Visual Acuity (UDVA)
Time frame: 4/6 months after surgery
Uncorrected Intermediate Visual Acuity (UIVA)
Time frame: 4/6 months after surgery
Uncorrected Near Visual Acuity (UNVA)
Time frame: 4/6 months after surgery
Distance Corrected Intermediate Visual Acuity (DCIVA)
Time frame: 4/6 months after surgery
Manifest Refraction
Time frame: 4/6 months after surgery
Defocus curve
Time frame: 4/6 months after surgery
Adverse events rates
Time frame: 4/6 months after surgery
Contrast Sensitivity
Time frame: 4/6 months after surgery
Halo and glare scores
Time frame: 4/6 months after surgery
Patient-reported outcomes: Quality of vision Questionnaire
Time frame: 4/6 months after surgery
Patient-reported outcomes: Spectacle independance Questionnaire
Time frame: 4/6 months after surgery
Patient-reported outcomes: open-ended question
Time frame: 4/6 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alain Saad, MD principal investigator
Hôpital Fondation Adolphe de Rothschild
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LuxHighAdd IOL and LuxGood IOL in people with Cataract, run by Cutting Edge SAS at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Line Bettinelli, OD (0619530701, line.bettinelli@bausch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distance Corrected Near Visual Acuity (DCNVA) (time frame: 4/6 months after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.