Comparative Study and Validation of New Methodologies for Measuring Addition

Essilor

Status

Enrolling

Conditions

Refraction Error

Presbyopia

Near Vision

Treatments

Device: Extended trial of addition

Device: Standard Subjective refraction

Device: Near vision examination and determination of additions

Device: Visual Acuity

Device: Binocular vision tests

Device: Objective refraction

Study type

Interventional

Funder types

Industry

Identifiers

NCT06963138

2023-A00122-43 (Other Identifier)

WS10331

Details and patient eligibility

About

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 value of an addition.

Full 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 objectively and/or subjectively.

The addition for near vision is most often obtained using so-called subjective devices, i.e., by relying on the patient's responses.

The state of the accommodative system can, however, be measured objectively using instruments available to prescribers (retinoscopes, automatic refractometers, aberrometers, etc.). These measurements can be used in clinical practice as a solid basis for the initial assessment of the subject's refractive status during a comprehensive eye examination. However, these measurements are not sufficient to determine the optimal correction to prescribe for near vision, i.e., one that achieves sufficient visual acuity and comfort to ensure effectiveness for the tasks a person wishes to perform in their daily life.

Indeed, subjective tests are considered the gold standard for prescribers, particularly when it comes to near vision testing. Also, there are numerous procedures for determining the appropriate addition to prescribe, and a wide variety of practices is observed among prescribers around the world. It is often necessary to perform multiple tests to ensure the correct addition value to recommend.

The aim of this study is to find ways of approaching the value of the ideal addition as accurately as possible, based on several parameters: measurements representative of subjects' near vision habits, optometric measurements to determine near vision addition, and measurements related to binocular vision and symptomatology. This data collection will enable to identify the most effective combination of measurements in order to determine the optimal near vision addition for a subject.

Enrollment

50 estimated patients

Sex

All

Ages

40 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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.