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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Myopia
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stéphane Boutinon, Master of Engineering; Phone Number: +33 6 77 16 43 83; Email: boutinos@essilor.fr

Study Locations

• France
  • France
    • Créteil, France, France, 94000
      • Essilor International - Ci&T 3
      • Contact: Stéphane Boutinon, Master of Engineering; Phone Number: +33 6 77 16 43 83; Email: boutinos@essilor.fr
      • Sub-Investigator: Amélia Sageat, Optometrist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Healthy Myopic Non-Presbyopic Adults

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Monocular Visual Acuity Distribution	Comparison of the distribution of monocular visual acuity obtained using the refraction from the investigational device versus the objective refraction from an autorefractometer.	Day One

Collaborators and Investigators

• Sponsor: Essilor International
• Investigators: Principal Investigator: Gildas Marin, PhD, Essilor International

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: December 9, 2025
• First Submitted That Met QC Criteria: December 9, 2025
• First Posted (Actual): December 22, 2025

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Ophthalmological; Ocular Physiological Phenomena; Vision Tests; Visual Acuity
• Other Study ID Numbers: WS10408

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No