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

May 21, 2026 updated by: Cutting Edge SAS

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
57

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Marseille, France, 13008
        • Recruiting
        • Centre d'Ophtalmologie des Dr Rozot et associés
        • Contact:
          • Dr Rozot, MD
          • Phone Number: +334 91 22 24 29
        • Principal Investigator:
          • Pascal ROZOT, MD
      • Montauban, France, 82000
      • Paris, France, 75019
        • Recruiting
        • Hôpital Fondation Adolphe de Rothschild
        • Principal Investigator:
          • Alain Saad, MD
        • Contact:
          • Alain Saad, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 informed consent.

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: LuxHighAdd
The experimental group will recieve the LuxHighAdd intraocular lens bilaterally.
Device: LuxHighAdd IOL
Bilateral implantation in the capsular bag to replace the cataractous human crystalline lens.
Active Comparator: LuxGood group
The control group will recieve the LuxGood intraocular lens bilaterally.
Device: LuxGood IOL
Bilateral implantation in the capsular bag to replace the cataractous human crystalline lens.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
4/6 months after surgery
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.
4/6 months after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Defocus curve
Time Frame: 4/6 months after surgery
Binocular defocus curve with the distance correction
4/6 months after surgery
Uncorrected Distance Visual Acuity (UDVA)
Time Frame: 4/6 months after surgery
Uncorrected photopic visual acuity at far in monocular and binocular with LuxHighAdd lens compared to LuxGood lens.
4/6 months after surgery
Uncorrected Intermediate Visual Acuity (UIVA)
Time Frame: 4/6 months after surgery
Uncorrected photopic visual acuity at intermediate distance in monocular and binocular with LuxHighAdd lens compared to LuxGood lens.
4/6 months after surgery
Uncorrected Near Visual Acuity (UNVA)
Time Frame: 4/6 months after surgery
Uncorrected photopic visual acuity at near distance in monocular and binocular with LuxHighAdd lens compared to LuxGood lens.
4/6 months after surgery
Distance Corrected Intermediate Visual Acuity (DCIVA)
Time Frame: 4/6 months after surgery
Photopic visual acuity at intermediate distance in monocular and binocular with best distance correction with LuxHighAdd lens compared to LuxGood lens.
4/6 months after surgery
Manifest Refraction
Time Frame: 4/6 months after surgery
Manifest subjective refraction
4/6 months after surgery
Adverse events rates
Time Frame: 4/6 months after surgery
Adverse events rates
4/6 months after surgery
Contrast Sensitivity
Time Frame: 4/6 months after surgery
Contrast Sensitivity in binocular conditions with distance correction
4/6 months after surgery
Halo and glare scores
Time Frame: 4/6 months after surgery
Halos and glare assessed with a simulator
4/6 months after surgery
Patient-reported outcomes: Quality of vision Questionnaire
Time Frame: 4/6 months after surgery
Assessment of quality of vision (CatQuest-9SF)
4/6 months after surgery
Patient-reported outcomes: Spectacle independance Questionnaire
Time Frame: 4/6 months after surgery
Assessment of spectacle independence (PRSIQ questionnaire )
4/6 months after surgery
Patient-reported outcomes: open-ended question
Time Frame: 4/6 months after surgery
Frequency and proportion of eyes with ocular and visual symptoms (non-directed complaints) using an open-ended question
4/6 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cutting Edge SAS

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alain Saad, MD, Hôpital Fondation Adolphe de Rothschild

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 19, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 6, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CE2301
  • 2023-A01904-41 (Registry Identifier: French BRC Identification number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings