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

NCT07297810 | Not Yet Recruiting

• 1 other identifier: WS10408
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myopia

Outcome Measures

Primary Outcomes (2)

• Difference of Optical Values

  Optical correction values obtained with the investigational device are compared with the values obtained using a phoropter (gold standard method - subjective refraction)

  Day One

• Difference in the proportion of visual acuity levels

  Comparison of the proportion of participants reaching specific monocular visual acuity levels (≥10/10 and ≥12/10) when wearing the refraction obtained from the investigational device versus the subjective refraction obtained from a phoropter (gold standard method)

  Day One

Secondary Outcomes (1)

• Comparison of Monocular Visual Acuity Distribution

  Day One

Study Arms (1)

Healthy Myopic Non-Presbyopic Adults

EXPERIMENTAL

Device: Optical correction values obtained with investigational device and visual acuity; Device: Optical correction values obtained with an autorefractometer and visual acuity; Device: Optical correction values obtained with a phoropter and visual acuity

Interventions

Optical correction values obtained with a phoropter and visual acuity DEVICE

Participants optical correction values are determined using a phoropter (subjective refraction) and their visual acuity is measured with this optical correction

Healthy Myopic Non-Presbyopic Adults

Optical correction values obtained with investigational device and visual acuity DEVICE

Participants optical correction values are determined using the investigational device and their visual acuity is measured with this optical correction

Healthy Myopic Non-Presbyopic Adults

Optical correction values obtained with an autorefractometer and visual acuity DEVICE

Participants optical correction values are determined using an autorefractometer (objective refraction) and their visual acuity is measured with this optical correction

Healthy Myopic Non-Presbyopic Adults

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Volunteers, fluent in French, willing to follow the protocol, able to read and understand the information form and give free and informed consent
• 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

You may not qualify if:

• 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)
• 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).

Sponsors & Collaborators

• Essilor International: lead

Study Sites (1)

Essilor International - Ci&T 3

Créteil, France, 94000, France

Location

MeSH Terms

Conditions

Myopia

Interventions

Visual Acuity

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Vision Tests; Diagnostic Techniques, Ophthalmological; Diagnostic Techniques and Procedures; Diagnosis; Ocular Physiological Phenomena

Study Officials

• Gildas Marin, PhD

  Essilor International

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stéphane Boutinon, Master of engineering

CONTACT

+33 6 77 16 43 83; boutinos@essilor.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: December 22, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)