Development of a New Device and Method to Assess the Degree of Myopia and/or Astigmatism in Myopic People
NCT ID: NCT07297810
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
30 participants
INTERVENTIONAL
2025-12-31
2027-09-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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Healthy Myopic Non-Presbyopic Adults
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
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
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
Interventions
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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
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
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
39 Years
ALL
Yes
Sponsors
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Essilor International
INDUSTRY
Responsible Party
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Principal Investigators
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Gildas Marin, PhD
Role: PRINCIPAL_INVESTIGATOR
Essilor International
Locations
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Essilor International - Ci&T 3
Créteil, France, France
Countries
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Central Contacts
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Stéphane Boutinon, Master of engineering
Role: CONTACT
Phone: +33 6 77 16 43 83
Email: [email protected]
Facility Contacts
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Stéphane Boutinon, Master of Engineering
Role: primary
Other Identifiers
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WS10408
Identifier Type: -
Identifier Source: org_study_id