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Not yet recruitingNCT07297810MDSW_DiVA2RxUpdated Dec 22, 2025

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

An interventional study of Optical correction values obtained with investigational device and visual acuity and Optical correction values obtained with an autorefractometer and visual acuity in Myopia, sponsored by Essilor International. Not yet recruiting at 1 site in France. Open to participants aged 18 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-22.

Sponsored by Essilor International · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 39 Years
Sex
All
01

Study 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.

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Conditions studied

  • Myopia

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03

In context

Myopia

984 studies on the registry are indexed under Myopia; 210 are open to participants now.

This study's planned enrollment of 30 is below the median of 80 across 783 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

Essilor International is the lead sponsor of 38 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 39 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Healthy Myopic Non-Presbyopic Adults

    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

  • DeviceOptical 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

  • DeviceOptical 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

  • DeviceOptical 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

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: Day One

  2. 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)

    Time frame: Day One

Secondary outcomes

  1. 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.

    Time frame: Day One

07

Study locations

1 site
  • Essilor International - Ci&T 3
    Créteil, France 94000, France
    • Stéphane Boutinon, Master of Engineering · Contact · boutinos@essilor.fr · +33 6 77 16 43 83
    • Amélia Sageat, Optometrist · Sub investigator
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07297810
Lead sponsor
Essilor International
Responsible party
Sponsor
First posted
Dec 22, 2025
Start date
Dec 2025 (estimated)
Primary completion
Jun 2027 (estimated)
Completion
Sep 2027 (estimated)
Last update
Dec 22, 2025

Study contacts

Stéphane Boutinon, Master of engineering
Contact
boutinos@essilor.fr
+33 6 77 16 43 83
Gildas Marin, PhD
principal investigator · Essilor International

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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