Menu
Not yet recruiting NCT07683481

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

No phase Interventional Myopia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HADAL Spectacle Lenses, Stellest® Spectacle Lenses.
Who it may be relevant to
Registry conditions: Myopia. Basic parameters: 6 years — 11 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Evaluation of Visual Comfort, Adaptation, and Satisfaction With a Myopia Control Lens in Myopic Children

Overview

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

Interventions

  • Device HADAL Spectacle Lenses
    Dispense to Test group for 2 weeks
  • Device Stellest® Spectacle Lenses
    Dispense to Control group for 2 weeks

Primary outcome measures

  • Successful Adaptation Rate Within 1 Week After Dispensing [Time frame: Within 1 week post dispensing]
Secondary outcome measures (5)
  • Successful Adaptation Rates at Early and Later Timepoints [Time frame: 4 days and 2 weeks post-dispensing]
  • Average daily and weekly wearing time [Time frame: Assessed at Day 4 and Week 2 post-dispensing]
  • Activity-specific visual comfort [Time frame: 4 days and 2 weeks post-dispensing]
  • Overall satisfaction [Time frame: 4 days and 2 weeks post-dispensing]
  • High-contrast visual acuity (distance and near) [Time frame: At dispensing (baseline) and 2 weeks post-dispensing]

Eligibility criteria

Inclusion criteria

  • 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.
  • Difference in SER (anisometropia) between two eyes should not exceed 1.50 D.
  • Best corrected Distance Visual Acuity (BCDVA) better than or equal to +0.10 LogMAR in each eye.
  • Be in good general health, based on the participant and the parent's/guardian's knowledge.

Exclusion criteria

  • 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.).
  • Current use of ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state.
  • History of ocular injury or surgery.
  • Participation in any clinical study within 30 days of the Baseline visit.
  • Sibling of existing participant of this study
  • Study participants deemed inappropriate for the study by the investigator.
  • The inherent ocular/systemic discomfort (dry eyes, visual fatigue, headaches, etc.) that may affect the evaluation of the study lens wearing experience, from the investigator's perspective.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07683481 · WS10506 · PIEC/2026/015

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗