Pilot Study on the Adaptation and Tolerance of Essilor® Myopia-control Spectacle Lenses
ConditionMyopia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-16
SponsorNantes University Hospital
About this trial
This observational pilot study aims to evaluate the adaptation and tolerance of Essilor® Stellest® myopia-control spectacle lenses in children with progressive myopia. The objective is to assess real-life compliance and comfort during lens wear, as these factors are essential for long-term therapeutic adherence and overall visual health outcomes
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 6 to 16 years with progressive myopia.
Spherical equivalent ≤ -0.50 D under cycloplegia and presence of at least one risk factor (age < 10 years, progression ≥ 0.50 D/year, axial length increase ≥ 0.2 mm/year, high myopia ≤ -6.00 D and/or axial length ≥ 26 mm, both parents myopic, at least one parent highly myopic, or Asian origin).
Patient covered by the French social security system.
Patient and legal guardians providing oral non-opposition to participate in the study.
Disqualifiers
Patients with strabismus, amblyopia, or syndromic myopia
Trial population
Children and adolescents with myopia followed at the Ophthalmology Departments of Nantes University Hospital and Strasbourg University Hospital, as well as at the Centre Ophtalmologique de l'Hippodrome in Lambersart.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
50 Participants
are grouped into 1 trial groupGroup A: pediatric patient with Essilor® myopia-control spectacle lenses
Trial outcomes
Primary outcomes
1
Adaptation and tolerance of Essilor® Stellest® 2.0 myopia-control spectacle lenses
Evaluation of the adaptation and tolerance of Essilor® Stellest® 2.0 lenses in children with progressive myopia, using the PREP-2 quality-of-life questionnaire (56 items) to assess comfort, visual satisfaction, and overall acceptance after regular use.
Time frame
At 6 months after initiation of lens wearSponsors and contacts
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Source ClinicalTrials.gov