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

Официальное название

Development of a New Device and Method for Determining Refractive Errors in a Myopic Population

Обзор

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.

Вмешательства

• Устройство Optical correction values obtained with investigational device and visual acuity
  Participants optical correction values are determined using the investigational device and their visual acuity is measured with this optical correction
• Устройство Optical correction values obtained with an autorefractometer and visual acuity
  Participants optical correction values are determined using an autorefractometer (objective refraction) and their visual acuity is measured with this optical correction
• Устройство Optical correction values obtained with a phoropter and visual acuity
  Participants optical correction values are determined using a phoropter (subjective refraction) and their visual acuity is measured with this optical correction

Первичные конечные точки

• Difference of Optical Values [Срок оценки: Day One]
• Difference in the proportion of visual acuity levels [Срок оценки: Day One]

Вторичные конечные точки (1)

• Comparison of Monocular Visual Acuity Distribution [Срок оценки: Day One]

Критерии участия

Критерии включения

• 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

Критерии исключения

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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

Франция · 1 центр

• Essilor International - Ci&T 3 — Créteil

Идентификаторы

NCT: NCT07297810 · WS10408

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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