Not yet recruiting NCT07297810
Development of a New Device and Method to Assess the Degree of Myopia and/or Astigmatism in Myopic People
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Optical correction values obtained with investigational device and visual acuity, Optical correction values obtained with an autorefractometer and visual acuity, Optical correction values obtained with a phoropter and visual acuity.
- Who it may be relevant to
- Registry conditions: Myopia. Basic parameters: 18 years — 39 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Development of a New Device and Method for Determining Refractive Errors in a Myopic Population
Overview
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.
Interventions
- Device 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 - Device 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 - Device 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
Primary outcome measures
- Difference of Optical Values [Time frame: Day One]
- Difference in the proportion of visual acuity levels [Time frame: Day One]
Secondary outcome measures (1)
- Comparison of Monocular Visual Acuity Distribution [Time frame: Day One]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
France · 1 center
- Essilor International - Ci&T 3 — Créteil
Identifiers
NCT: NCT07297810 · WS10408