Comparing Myopia Control Spectacle Lenses for Visual Comfort, Adaptation, and Satisfaction in Myopic Children

ConditionMyopia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-11
SponsorEssilor International

About this trial

The goal of this clinical trial is to demonstrate that the visual comfort, adaptation, and overall satisfaction associated with the use of the test spectacle lenses are not inferior to those of the control spectacle lenses in myopic children age ≥ 6 years and \< 11 years old, both male and female, with no systemic or ocular anomalies. The main question it aims to answer is:

Do children adapt to the test spectacle lenses within the first 1-2 weeks of wear without significant symptoms or complaints?

Is the level of visual comfort and overall satisfaction with test spectacle lenses comparable to that of control spectacle lenses during the early adaptation period?

Researchers will compare questionnaire responses between participants wearing test lenses and those wearing control lenses to assess whether the test lenses are non-inferior in terms of visual comfort, adaptation, and user satisfaction.

Participants will:

* Wear the study spectacles for 2 weeks * Respond to questionnaires 4 days after dispensing and at 2 weeks * Visit Essilor R\&D Centre for screening, dispensing and follow up sessions

Eligibility criteria

Qualifiers

Volunteer participant who is willing and able to comply with all scheduled study visits.

Informed consent of parent/guardian and assent of participant.

Age ≥ 6 years and < 11 years at the time of signing informed consent and assent.

Spherical equivalent refraction (SER) equal or less than -0.50D and equal or greater than -4.75D with astigmatism not more than 2.00 D on both eyes.

Disqualifiers

History of Atropine, Orthokeratology, Contact Lens or Red Light treatment.

Strabismus by cover test at near or distance wearing correction.

History and presence of amblyopia.

Any ocular or systemic condition known to affect refractive status (e.g. keratoconus, diabetes, Downs syndrome, or other developmental disorders, etc.).

Trial design

Treatments tested in this trial

  • HADAL Spectacle Lenses
  • Stellest® Spectacle Lenses

Treatment groups

20 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators