Bicentric Clinical Investigation to Assess Safety and Performance of LuxHighAdd IOL

NCT06446817 | Recruiting

• 2 other identifiers: CE23012023-A01904-41
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Cataract

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  4/6 months after surgery

Secondary Outcomes (12)

• Uncorrected Distance Visual Acuity (UDVA)

  4/6 months after surgery

• Uncorrected Intermediate Visual Acuity (UIVA)

  4/6 months after surgery

• Uncorrected Near Visual Acuity (UNVA)

  4/6 months after surgery

• Distance Corrected Intermediate Visual Acuity (DCIVA)

  4/6 months after surgery

• Manifest Refraction

  4/6 months after surgery

Study Arms (2)

LuxHighAdd

EXPERIMENTAL

The experimental group will recieve the LuxHighAdd intraocular lens bilaterally.

Device: LuxHighAdd IOL

LuxGood group

ACTIVE COMPARATOR

The control group will recieve the LuxGood intraocular lens bilaterally.

Device: LuxGood IOL

Interventions

LuxHighAdd IOL DEVICE

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

LuxHighAdd

LuxGood IOL DEVICE

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

LuxGood group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cutting Edge SAS: lead

Study Sites (2)

Hôpital Fondation Adolphe de Rothschild

Paris, 75019, France

RECRUITING

WestOphta

Rennes, 35000, France

RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Alain Saad, MD

  Hôpital Fondation Adolphe de Rothschild

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Line Bettinelli, OD

CONTACT

0619530701; line.bettinelli@cutting-edge.fr

Christophe Cesses

CONTACT

0786991458; christophe.cesses@cutting-edge.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: June 6, 2024
• Study Start: December 19, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 12, 2025

Record last verified: 2024-05

Locations

FR (2)