Status:
COMPLETED
Comparative Study and Validation of New Methodologies for Measuring Addition
Lead Sponsor:
Essilor International
Conditions:
Presbyopia
Near Vision
Eligibility:
All Genders
40-60 years
Phase:
NA
Brief Summary
The aim of this research is to collect comprehensive data on a presbyopic population that may require near vision correction, in order to identify the most useful tests to accurately determine the val...
Detailed Description
Refraction is the key point of an ophthalmic examination when visual correction is required for distance vision, as is determining the addition for near vision. These measurements can be obtained obje...
Eligibility Criteria
Inclusion
- Volunteer, fluent in French, willing to follow the protocol, able to read and understand the information form and give free and informed consent
- Aged 40 to 60 years
- Individual with monocular visual acuity ≥ +0.1 LogMAR with current corrections and pinhole if necessary
- Individual with a visual acuity difference ≤ 0.2 LogMAR with current corrections
- Individual with stable binocular vision in distance and near vision
Exclusion
- Age \< 40 years (i.e., no minors in accordance with Article L1121-7)
- Age \> 60 years
- All categories of people specifically protected under French law are excluded from this research (Articles L1121-5 to L1121-9 of the Public Health Code):
- Pregnant, childbearing, or breastfeeding women (Article L1121-5)
- Persons deprived of their liberty by a judicial or administrative decision and persons hospitalized without consent pursuant to Articles L. 3212-1 and L. 3213-1 who do not fall under the provisions of Article L. 1121-8 and persons admitted to a health or social care facility for purposes other than research
- Adults incapable or unable to express consent (Article L1121-8)
- Participants currently excluded from another study
- Participants unable to be contacted in case of emergency
- Person with strabismus
- Person with amblyopia
- Aphakic or pseudophakic person
- Person with vertical phoria \> 1 PD
- Declared neurological deficit, including a history of epileptic disorders or sensory-motor coordination disorders, vestibular or cerebellar pathology (e.g., balance disorders)
- Declared severe ocular pathology, involving visual field loss, such as glaucoma, or involving loss of acuity and significant discomfort in dimly or excessively lit environments, such as retinitis pigmentosa, or declared and treated dry eye.
Key Trial Info
Start Date :
March 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 5 2025
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT06963138
Start Date
March 31 2025
End Date
May 5 2025
Last Update
June 6 2025
Active Locations (1)
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1
Essilor International - Ci&T 2
Créteil, France, 94000