CAtaract ASSessment of IntrOcular Lens Objective PErformancE

NCT ID: NCT06168617

Last Updated: 2023-12-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-31
• Study Completion Date: 2026-01-31

Brief Summary

Prospective, interventional, non-invasive, monocentric, longitudinal, non-randomized study

Detailed Description

There are many strategies for restoring vision after cataract surgery. They all involve the use of intraocular lenses (IOLs) to correct a single focal length (monofocal lenses) or several focal lengths (multifocal lenses). Each focal length corrected by the implants represents a distance of clear vision for patients. The complexity of the optical design and the neurosensory adaptation required for this restoration may present a downside, as implant patients may complain of light halos, glare or problems with depth perception, depending on the case.

Existing validated techniques are not sufficient to accurately assess the benefits or difficulties in the daily lives of elderly patients, the a With this project, the patient and his or her autonomy become the focus of the evaluation of IOL performance, particularly for IOLs of recent design, which makes it possible to better characterise the consequences of their implantation. PerfO studies of IOLs used in cataract surgery will be based on objectives tasks inspired by daily life performed by patients according to Street Lab procedures.

Conditions

Cataract

Keywords

Cataract; Intraocular Lens

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Pilot phase

5 patients of both 3 groups will perform the parametric studying tasks. This phase aims at determine the feasibility of the tasks according to their parameters : Guided walk, visuo-manual task and posturography.

Group Type: EXPERIMENTAL

Performance tasks in daily life

Intervention Type: DIAGNOSTIC_TEST

Evaluation of performance tests executed by patients in real-life situations.

Validation phase

20 patients of both 3 groups will perform these performance tasks. This phase is designed to evaluate the performance tests executed by patients in real-life situations.

Group Type: EXPERIMENTAL

Performance tasks in daily life

Intervention Type: DIAGNOSTIC_TEST

Evaluation of performance tests executed by patients in real-life situations.

Interventions

Performance tasks in daily life

Evaluation of performance tests executed by patients in real-life situations.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Male / Female
• 65-75 years old
• Pseudophakia, implanted with 2 trifocal IOL or 2 EDOF IOL or with 2 monofocal IOL calculated for monovision
• Second eye surgery performed > 1 month before inclusion with stable residual refraction
• No degenerative or neurological disease
• Good understanding of the French language
• No use of an aid to locomotion (example: cane, etc...)
• Binocular far non corrected visual acuity ≥ 8/10
• Refraction at distance vision

• Spherical equivalent in distance vision ≤ 0.75 diopter
• Cylinder ≤ 0.75 diopter

Monovision group :

> Addition=1.25 diopter ±0.50

Multifocal group :

• Monocular far non corrected visual acuity ≥ 8/10
• ATLISA tri (Zeiss)

EDOF group :

• Monocular far non corrected visual acuity ≥ 8/10
• Eyehance (J&J)

Exclusion Criteria

Media opacity or eye movement disorder (nystagmus) that interferes with retinal imaging data quality in the opinion of the investigator ;

• Media opacity or eye movement disorder (nystagmus) that interferes with retinal imaging data quality in the opinion of the investigator ;
• Any concurrent intraocular condition that, in the opinion of the investigator would either require surgical intervention during the study to prevent or treat visual loss that might result from that condition or affect interpretation of study results ;
• Known systemic illness which in the opinion of the investigator will prevent from actively participating in the study ;
• Concomitant treatment in either eye (concomitant use of vitamins/supplements is not excluded) ;
• Inability to comply with study task instructions or study visits ;
• Medication that may cause motor, visual or cognitive impairment (PSAs, neuroleptics, etc.) or interfere with study evaluations ;
• Other uncontrolled ophthalmic conditions that may interfere with study evaluation ;
• Participation in another clinical trial that may interfere with the present study ;
• Cognitive impairment, illiteracy, and subjects who do not speak the national language ;
• Paralysis may compromise ability to perform manual grasping tasks ;
• Pregnant or breastfeeding woman ;
• Patient under legal protection ("curatelle" or "tutelle") ;
• Patient denied freedom by a legal or administrative order.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role: collaborator

StreetLab Vision

INDUSTRY

Sponsor Role: collaborator

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anna GEMAHLING

Role: PRINCIPAL_INVESTIGATOR

Fondation Hôpital Adolphe de Rothschild

Erci GABISON

Role: STUDY_DIRECTOR

Fondation Hôpital Adolphe de Rothschild

Central Contacts

Nabil BROUK

Role: CONTACT

Phone: +33140021126

Email: nbrouk@15-20.fr

Hayet SERHANE

Role: CONTACT

Phone: +33140021144

Email: hserhane@15-20.fr

Other Identifiers

P22-08

Identifier Type: -

Identifier Source: org_study_id