Development of a New Device and Method to Assess the Degree of Myopia and/or Astigmatism in Myopic People (MDSW_DiVA2Rx)

Essilor

Status

Not yet enrolling

Conditions

Myopia

Treatments

Device: Optical correction values obtained with an autorefractometer and visual acuity

Device: Optical correction values obtained with a phoropter and visual acuity

Device: Optical correction values obtained with investigational device and visual acuity

Study type

Interventional

Funder types

Industry

Identifiers

NCT07297810

WS10408

Details and patient eligibility

About

The purpose of this clinical investigation is to check whether the new device can correctly measure a person's degree of myopia and astigmatism.

To evaluate and improve the device's performance, the results (optical correction values and the associated visual acuity) obtained with the investigational device will be compared with the results obtained using standard instruments commonly used by eye care professionals.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 39 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Volunteers, fluent in French, willing to follow the protocol, able to read and understand the information form and give free and informed consent
Aged between 18 and 39 years at the time of study inclusion
Wear corrective glasses
With an ophthalmologist's prescription for corrective eyewear less than 3 years old
Spherical error of each meridian within the range of [-5.00 ; -0.50 D]
Cylindrical defect included in interval [-4.50 ; 0.00 D]
Corrected monocular visual acuity ≤ 0.0 logMAR for distance vision (≥10/10)
French Social Security beneficiary

Exclusion criteria

General criteria for non-inclusion:

Essilor International employee
Pregnant, or breast-feeding women (Article L1121-5)
Persons deprived of their liberty by a judicial or administrative decision and persons hospitalized without consent under Articles L. 3212-1 and L. 3213-1 who are not covered by the provisions of Article L. 1121-8 and persons admitted to a health or social establishment for purposes other than research
Adults incapable or unable to express consent (Article L1121-8)
Participant included in another ongoing study or in a period of exclusion
All categories of persons particularly protected under French law are excluded from this research (Articles L1121-5 to L1121-9 of the French Public Health Code)
Amblyopia, strabismus, nystagmus
Wearing progressive lenses

The following elements are considered based on the participant's declaration :

Declared cataract, Aphakia (without lens) or pseudophakia (with intraocular implant)
Ocular surgery (iridectomy, refractive surgery, corneal transplant)
Ocular trauma (corneal deformation, contusion, chemical burn, foreign body intrusion, perforation, orbital fracture, enucleation)
Severe ocular pathology, involving loss of visual field as in glaucoma or retinitis pigmentosa, involving loss of acuity and severe discomfort in dimly or brightly lit environments as in Age related macular degeneration (AMD) or overt and treated dry eye.
Systemic pathology affecting vision (diabetes, uncontrolled blood pressure, myasthenia gravis, etc.).
Medication that may affect vision or interfere with study measures (antidepressants, medication with atropine-like effects).
Declared neurological deficits, in particular a history of epileptic pathology or sensory-motor coordination disorders, vestibular or cerebellar pathology (e.g. balance disorders).