Bicentric Clinical Investigation to Assess Safety and Performance of LuxHighAdd IOL

Cataract Clinical Trial

— HIGHADD  

Official title:

Multicentric Clinical Investigation to Determine Safety and Efficacy of a Hydrophobic Acrylic Multifocal Intraocular Lens

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06446817
• Other study ID #: CE2301
• Secondary ID: 2023-A01904-41
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: July 1, 2026

Study information

• Verified date: May 2024
• Source: Cutting Edge SAS
• Contact: Line Bettinelli, OD
• Phone: 0619530701
• Email: line.bettinelli[@]cutting-edge.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 57
• Est. completion date: July 1, 2026
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• LuxHighAdd IOL
Bilateral implantation in the capsular bag to replace the cataractous human crystalline lens.
• LuxGood IOL
Bilateral implantation in the capsular bag to replace the cataractous human crystalline lens.

Locations

Country	Name	City	State
France	Hôpital Fondation Adolphe de Rothschild	Paris
France	WestOphta	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Cutting Edge SAS

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Uncorrected Distance Visual Acuity (UDVA)	Uncorrected photopic visual acuity at far in monocular and binocular with LuxHighAdd lens compared to LuxGood lens.	4/6 months after surgery
Secondary	Uncorrected Intermediate Visual Acuity (UIVA)	Uncorrected photopic visual acuity at intermediate distance in monocular and binocular with LuxHighAdd lens compared to LuxGood lens.	4/6 months after surgery
Secondary	Uncorrected Near Visual Acuity (UNVA)	Uncorrected photopic visual acuity at near distance in monocular and binocular with LuxHighAdd lens compared to LuxGood lens.	4/6 months after surgery
Secondary	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.	4/6 months after surgery
Secondary	Manifest Refraction	Manifest subjective refraction	4/6 months after surgery
Secondary	Defocus curve	Binocular defocus curve with the distance correction	4/6 months after surgery
Secondary	Adverse events rates	Adverse events rates	4/6 months after surgery
Secondary	Contrast Sensitivity	Contrast Sensitivity in binocular conditions with distance correction	4/6 months after surgery
Secondary	Halo and glare scores	Halos and glare assessed with a simulator	4/6 months after surgery
Secondary	Patient-reported outcomes: Quality of vision Questionnaire	Assessment of quality of vision (CatQuest-9SF)	4/6 months after surgery
Secondary	Patient-reported outcomes: Spectacle independance Questionnaire	Assessment of spectacle independence (PRSIQ questionnaire )	4/6 months after surgery
Secondary	Patient-reported outcomes: open-ended question	Frequency and proportion of eyes with ocular and visual symptoms (non-directed complaints) using an open-ended question	4/6 months after surgery