How teenagers with and without myopia hold things and move when wearing different eyeglass prescriptions
Comportement Visuo-postural Des Adolescents Myopes et Non Myopes (CALYPSO)
This study will test whether different eyeglass prescriptions, including Stellest lenses, change how close teenagers hold objects and how they move during everyday near tasks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 12 Years to 17 Years |
| Sex | All |
| Sponsor | Essilor International Industry-sponsored |
| Locations | 1 site (Paris) |
| Trial ID | NCT07440134 on ClinicalTrials.gov |
What this trial studies
This observational study compares three groups of 12- to 17.5-year-old adolescents: non-myopic teens, myopic teens wearing single-vision lenses, and myopic teens wearing Essilor Stellest lenses. Participants first receive an optometric exam and then return for a motion-capture session while doing everyday near tasks, during which eye-to-object distance and postural movements are measured. The investigators will compare average working distances and posture metrics across the three groups to see if lens type is associated with different visual or postural behavior. The study is conducted at a single site in Paris and is sponsored by Essilor International.
Who should consider this trial
Good fit: Ideal candidates are French-speaking adolescents aged 12 to 17 years and 6 months with no visual or cognitive disorders, who are either non-myopic within the specified refraction range or myopic with a prescription between -6.5D and -0.5D and who wear single-vision or Stellest lenses (Stellest wearers must have used them for at least two months).
Not a fit: Those unlikely to benefit include people outside the 12–17.5 age range, those with eye disease or cognitive impairments, non–French speakers, and individuals who cannot attend in-person visits at the Paris site.
Why it matters
Potential benefit: If results show lens type affects working distance or posture, the findings could help clinicians and families choose lenses that reduce close viewing behaviors linked to eye strain or myopia progression.
How similar studies have performed: Myopia-control lenses such as Stellest have demonstrated effectiveness at slowing myopia progression in previous clinical trials, but using motion-capture to compare working distance and posture across lens types is a relatively new application.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Paris
- Paris Bastille — Paris, France (Recruiting)
Study contacts
- Study coordinator: David Rio, Phd
- Email: riod@essilor.fr
- Phone: +33(0)155964840
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.