CAtaract ASSessment of IntrOcular Lens Objective PErformancE

NCT06168617 | Unknown

• 1 other identifier: P22-08
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Cataract

Keywords

Cataract; Intraocular Lens

Outcome Measures

Primary Outcomes (4)

• Locomotion - Guided walk

  The operator measure the success and completion rates for daily life tests: The performance is measured with the walking speed and the foot placement precision. The walking balance is also evaluated by recording the pelvis position.

  3 months

• Static and dynamic posturography with optical flow:

  Postural control will be described by the Root Mean Square (RMS) of body sway in sagittal and coronal plans, the path length of the projection of the center of mass (CoM), the sway area described by the confidence ellipse which is the region that contains 95% of all COM samples. To better understand the visual, vestibular and somatosensory contributions on postural control, Romberg quotient (QR), Visual ratio (ViR), vestibular ratio (VeR) and somatosensory ratio (SR) will be calculated thanks to sensory conditions. Correlations with visual functions will be realized and postural deficits will be integrated into the locomotion score as a covariable.

  3 months

• Visuo-manual task

  The variables analyzed :the duration of the visual search, which will be an indicator of the quality and ease of vision ; the duration of the grasping movement, which will be an indicator of the ease of the approach movement towards a low contrast object ; the duration between the seizure of the object and its deposit, which will be an indicator of the sensitivity to contrast ; the number of errors (wrong object grasped, object dropped, ...), will be an indicator of insufficient vision to perform the task.

  3 months

• Quality of life

  French version Adapted Catquest-9SF questionnaire. It is a psychometric questionnaire specifically designed for cataracts. It assesses patient satisfaction with their eyesight. It consists of nine questions divided into two parts. The first part concerns two questions on the general quality of vision perceived by the patient, and the second part concerns seven questions on the difficulties that vision can cause on daily activities. The first page contains an explanatory note on the questionnaire. The patients' answers are divided into four equal boxes designating the degree of difficulty: very great difficulty, great difficulty, moderate difficulty and no difficulty.

  3 months

Study Arms (2)

Pilot phase

EXPERIMENTAL

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.

Diagnostic Test: Performance tasks in daily life

Validation phase

EXPERIMENTAL

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.

Diagnostic Test: Performance tasks in daily life

Interventions

Performance tasks in daily life DIAGNOSTIC_TEST

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

Pilot phase; Validation phase

Eligibility Criteria

• Age: 65 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Male / Female
• years old
• Pseudophakia, implanted with 2 trifocal IOL or 2 EDOF IOL or with 2 monofocal IOL calculated for monovision
• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts: lead
• Fondation Ophtalmologique Adolphe de Rothschild: collaborator
• StreetLab Vision: collaborator

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Anna GEMAHLING

  Fondation Hôpital Adolphe de Rothschild

  PRINCIPAL INVESTIGATOR

• Erci GABISON

  Fondation Hôpital Adolphe de Rothschild

  STUDY DIRECTOR

Central Study Contacts

Nabil BROUK

CONTACT

+33140021126; nbrouk@15-20.fr

Hayet SERHANE

CONTACT

+33140021144; hserhane@15-20.fr

Study Design

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

Model Details: Prospective, interventional, non-invasive, monocentric, longitudinal, non-randomized study

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 13, 2023
• Study Start: January 1, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: December 19, 2023

Record last verified: 2023-12