Status:
NOT_YET_RECRUITING
CAtaract ASSessment of IntrOcular Lens Objective PErformancE
Lead Sponsor:
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Collaborating Sponsors:
Fondation Ophtalmologique Adolphe de Rothschild
StreetLab Vision
Conditions:
Cataract
Eligibility:
All Genders
65-75 years
Phase:
NA
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 length...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06168617
Start Date
January 1 2024
End Date
January 1 2026
Last Update
December 19 2023
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