Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07297810

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Essilor International - Ci&T 3

Créteil, France, 94000

Location contact

Amélia Sageat, Optometrist

SUB_INVESTIGATOR

Stéphane Boutinon, Master of Engineering

CONTACT

[email protected]

+33 6 77 16 43 83

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

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

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

Primary outcomes

  1. Difference of Optical Values

    Time frame: Day One

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

  2. Difference in the proportion of visual acuity levels

    Time frame: Day One

    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)

Secondary outcomes

  1. Comparison of Monocular Visual Acuity Distribution

    Time frame: Day One

    Comparison of the distribution of monocular visual acuity obtained using the refraction from the investigational device versus the objective refraction from an autorefractometer.

Study contacts

Contact information is provided by the study sponsor or research team.

Stéphane Boutinon, Master of engineering

CONTACT

[email protected]

+33 6 77 16 43 83

Sponsors and collaborators

Lead sponsor

Essilor International

Industry

Registry information

Official study title

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

Acronym: MDSW_DiVA2Rx

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 22, 2025
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.