Visual and Postural Behavior in Myopic and Non-Myopic Teenagers (CALYPSO)

April 2, 2026 updated by: Essilor International

Comportement Visuo-postural Des Adolescents Myopes et Non Myopes (CALYPSO)

The goal of this observational study is to learn whether different types of eyeglasses prescription and different types of lenses change how close teenagers hold objects when looking at them up close. The study includes adolescents who are non-myopic and adolescents who are myopic and wear either single-vision lenses or lenses slowing down myopia progression.

The main questions it aims to answer are:

Do teenagers in these three groups use different average working distances (eye-to-object distance) during everyday tasks?

Does wearing Essilor® Stellest® lenses change working distance compared with wearing single-vision lenses?

Researchers will compare the three groups to see if their working distances differ.

Participants will:

Complete an initial optometric eye examination.

Come for a second visit where they perform everyday activities while wearing a motion-capture system that measures how they move and how far they hold objects.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: David Rio, Phd
  • Phone Number: +33(0)155964840
  • Email: riod@essilor.fr

Study Contact Backup

Study Locations

  • France
      • Paris, France, 75012
        • Recruiting
        • Paris Bastille
        • Contact:
          • David Rio, Main investigator
          • Phone Number: +33(0)155964840
          • Email: riod@essilor.fr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Volunteer adolescent, fluent in French, able to follow protocol and read and write
  • Aged between 12 and 17 years and 6 months
  • Adolescent with no history, according to the participant and/or their legal representatives, of any pathology, deficit, or disorder that could interfere with visual or cognitive functions.
  • If the subject wears glasses, they must have an ophthalmic prescription dated within the last year, certifying that a consultation was carried out during the previous year
  • If the subject wears Essilor® Stellest® 1.0 lenses, they must have worn them for at least two (2) consecutive months prior to inclusion in the study.
  • If the subject is nearsighted: -6.5D ≤ equivalent sphere ≤ -0.5D with usual correction
  • If the subject is not nearsighted: -0.5 < equivalent sphere ≤ +2.5

Exclusion Criteria:

  • Age ≤ 12 years
  • Age > 17 years and 6 months
  • Pregnant or breastfeeding women (Article L1121-5)
  • Persons (legal representatives or subjects) deprived of their liberty by a judicial or administrative decision and persons hospitalized without consent pursuant to 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 care facility for purposes other than research
  • Participants who are currently excluded from another study
  • All categories of persons who are particularly protected under French law are excluded from this research (Articles L1121-5 to L1121-9 of the Public Health Code)
  • Declared neurological deficit, in particular a history of epileptic pathology or sensorimotor coordination disorders, vestibular or cerebellar pathology (e.g., balance disorders)
  • Severe declared eye disease involving loss of visual field, such as glaucoma, involving loss of acuity and severe discomfort in low-light or overly bright environments, such as retinitis pigmentosa, or declared and treated dry eye syndrome.
  • Gougerot-Sjögren syndrome or declared dry eye syndrome
  • Declared aphakia or pseudophakia (intraocular implant)
  • Declared systemic pathology, medical treatment, or medication with an effect on vision
  • People with declared muscle paralysis
  • Binocular vision problems such as amblyopia, strabismus, or nystagmus
  • Children of employees or employees of Essilor International, Luxottica, GrandVision, and their subsidiaries
  • Individuals who have undergone previous refractive surgery, have a history of strabismus surgery, or have a history of any type of eye surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: non-myopic teenagers
Device: Ophtalmic measurements
Participants will undergo a standard ophthalmic examination during the initial visit. All procedures are non-invasive, non-ionising, and conducted using devices routinely employed in clinical ophthalmic practice.
Behavioral: Visuo-postual measurements
The behavioral part of the study consists of a set of tasks designed to assess eye movements and visual behavior in both controlled and ecological conditions. Participants perform everyday activities while eye movements and body motion are recorded using an eye tracker and motion capture systems.
Experimental: myopic teenagers wearing Essilor® Stellest® lenses
Device: Ophtalmic measurements
Participants will undergo a standard ophthalmic examination during the initial visit. All procedures are non-invasive, non-ionising, and conducted using devices routinely employed in clinical ophthalmic practice.
Behavioral: Visuo-postual measurements
The behavioral part of the study consists of a set of tasks designed to assess eye movements and visual behavior in both controlled and ecological conditions. Participants perform everyday activities while eye movements and body motion are recorded using an eye tracker and motion capture systems.
Experimental: myopic teenagers wearing single vision lenses
Worn lenses do not have a myopia-control effect
Device: Ophtalmic measurements
Participants will undergo a standard ophthalmic examination during the initial visit. All procedures are non-invasive, non-ionising, and conducted using devices routinely employed in clinical ophthalmic practice.
Behavioral: Visuo-postual measurements
The behavioral part of the study consists of a set of tasks designed to assess eye movements and visual behavior in both controlled and ecological conditions. Participants perform everyday activities while eye movements and body motion are recorded using an eye tracker and motion capture systems.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Working distance using motion capture system
Time Frame: From enrollment to 3 months after enrollment
Quantitative assessment of working distance in meters during near vision tasks using a motion capture system
From enrollment to 3 months after enrollment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gaze behavior during near vision tasks accessed with an eye-tracking system
Time Frame: From enrollment to 3 months after enrollment
Assessment of eye movements (spatial coordinates) during near vision tasks
From enrollment to 3 months after enrollment
Posture, eye-head coordination during near-vision tasks (with motion capture system)
Time Frame: From enrollment to 3 months after enrollment
Quantitative evaluation of postural behavior (spatial coordinates of body parts) while performing near vision tasks.
From enrollment to 3 months after enrollment
Correlation coefficient (R2) between optometric profile and near-vision behavior
Time Frame: From enrollment to 3 months after enrollment
Statistical analysis of the association between participants' optometric characteristics and their near vision behavioral patterns.
From enrollment to 3 months after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Essilor International

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 3, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WS10477
  • 2025-A02517-42 (Registry Identifier: ANSM RCB)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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