Clinical trial NCT06168617: CAtaract ASSessment of IntrOcular Lens Objective PErformancE
Official title: Feasibility Study of Tests, on the Model of Real-life Daily Tasks, Measuring the Performance of Different Vision Restoration Strategies, After Cataract Surgical Treatment With Different Types of Intraocular Lens Implants.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cataract
Keywords: Cataract
Intraocular Lens
Lead sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Sponsor class: OTHER
Collaborators: name: Fondation Ophtalmologique Adolphe de Rothschild
name: StreetLab Vision
First posted: 2023-12-13
Enrollment: 75
Sex: ALL
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, interventional, non-invasive, monocentric, longitudinal, non-randomized study
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Locomotion - Guided walk
timeFrame: 3 months
measure: Static and dynamic posturography with optical flow:
timeFrame: 3 months
measure: Visuo-manual task
timeFrame: 3 months
measure: Quality of life
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Fondation Hôpital Adolphe de Rothschild
name: Anna GEMAHLING
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondation Hôpital Adolphe de Rothschild
name: Erci GABISON
role: STUDY_DIRECTOR
References: