Assessing the safety and performance of a new intraocular lens for cataract surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical investigation aims to evaluate the safety and performance of the LuxHighAdd intraocular lens (IOL) when implanted bilaterally in patients with cataracts. Participants will be compared to those receiving the LuxGood monofocal lens to determine the effectiveness of the new multifocal lens. The study will involve patients aged 50 and over who meet specific eligibility criteria, ensuring a controlled environment for accurate results. The primary focus is on the outcomes related to vision improvement and safety post-implantation.

Why it matters

Who can join: the full rules

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

Where it's running

• Centre d'Ophtalmologie des Dr Rozot et associés
  Marseille, France Recruiting
• Clinique Honoré Cave
  Montauban, France Recruiting
• Hôpital Fondation Adolphe de Rothschild
  Paris, France Recruiting

Study contacts

• Principal investigator: Alain Saad, MD — Hôpital Fondation Adolphe de Rothschild
• Study coordinator: Line Bettinelli, OD
• Email: line.bettinelli@bausch.com
• Phone: 0619530701

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Visual adaptation and quality of life after different IOL implantation options

  This study follows adults who have cataracts and receive bilateral multifocal or mixed IOLs to see how their vision and daily life improve over 6 months.

  Recruiting Sichuan Academy of Medical Sciences · Chengdu · NCT07740590

• Corneal Biomechanics and Surgical Astigmatism after Cataract Surgery in Pseudoexfoliation

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• Neuroplastic pain education and guided breathing during awake cataract surgery

  This trial tests whether the STEIN Protocol, a non-drug approach with pain education, guided imagery, and paced breathing, helps adults having cataract surgery require less pain medicine and feel less anxious.

  Recruiting University of California, Los Angeles · Los Angeles, California · NCT07715591

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.