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

2 juli 2026 bijgewerkt door: Essilor International

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

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

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

20

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

  • Naam: Thomas Boudenne

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Test
Test Lens
Apparaat: HADAL Spectacle Lenses
Dispense to Test group for 2 weeks
Actieve vergelijker: Control
Control Lens
Apparaat: Stellest® Spectacle Lenses
Dispense to Control group for 2 weeks

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Successful Adaptation Rate Within 1 Week After Dispensing
Tijdsspanne: Within 1 week post dispensing

Proportion of children who meet all of the following criteria at the 1-week visit:

  1. Self-reported adaptation: The child confirms feeling adapted to the assigned study lenses, as captured by a pre-specified question in the study questionnaire
  2. Absence or resolution of symptoms: The child reports either (i) no symptoms since dispensing, or (ii) complete resolution of any symptoms initially reported at the 4-day visit, as assessed through the symptom checklist in the study questionnaire
  3. No lens discontinuation: The child has not discontinued wear of the assigned study lenses prior to the 1-week visit.

Non-inferiority of the test lenses will be evaluated against the control lenses based on the between-group difference in adaptation success rates, using a pre-specified non-inferiority margin.
Within 1 week post dispensing

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Successful Adaptation Rates at Early and Later Timepoints
Tijdsspanne: 4 days and 2 weeks post-dispensing

Proportion of children who meet all of the following criteria at approximately Day 4 and Week 2 post-dispensing:

  1. Self-reported adaptation: The child confirms feeling adapted to the assigned study lenses, as captured by a pre-specified question in the study questionnaire
  2. Absence or resolution of symptoms: The child reports either (i) no symptoms since dispensing, or (ii) complete resolution of any symptoms initially reported at the previous visit, as assessed through the symptom checklist in the study questionnaire
  3. No lens discontinuation: The child has not discontinued wear of the assigned study lenses prior to the respective visit

Between-group differences in adaptation success rates between the test and control spectacle lenses will be evaluated at both timepoints.
4 days and 2 weeks post-dispensing
Average daily and weekly wearing time
Tijdsspanne: Assessed at Day 4 and Week 2 post-dispensing
Mean daily wearing time (hours/day) and total weekly wearing time (hours/week) of the assigned study spectacles will be compared between the test and control groups, based on participant/parent-reported wear time.
Assessed at Day 4 and Week 2 post-dispensing
Activity-specific visual comfort
Tijdsspanne: 4 days and 2 weeks post-dispensing
Participant-reported visual comfort during daily activities (including far vision, intermediate vision, near vision with and without digital devices, and overall vision) will be evaluated using the specific comfort subscale items from the unabbreviated Visual Comfort and Adaptation Questionnaire (Child). Individual comfort items are rated on a 4-point Likert scale ranging from 1 (Strongly disagree) to 4 (Strongly agree). Negatively worded comfort questions are reverse-coded prior to analysis so that all values are directionally aligned. The subscale score is calculated as the mean of these items, yielding a minimum value of 1 and a maximum value of 4, where a higher score indicates a better outcome (greater visual comfort during daily activities). Between-group differences between the test and control spectacle lenses will be evaluated at each specified timepoint.
4 days and 2 weeks post-dispensing
Overall satisfaction
Tijdsspanne: 4 days and 2 weeks post-dispensing
Overall satisfaction with the study spectacles will be evaluated using the satisfaction subscale items (e.g., "I hate wearing the new spectacles" and "I like my new spectacles") from the unabbreviated Visual Comfort and Adaptation Questionnaire (Child). Individual items are rated on a 4-point Likert scale ranging from 1 (Strongly disagree) to 4 (Strongly agree). Negatively worded items are reverse-coded during data analysis. Subscale scores are calculated as the mean of the items, ranging from a minimum value of 1 to a maximum value of 4, where higher scores indicate a better outcome (higher satisfaction with the spectacles). Between-group differences between the test and control spectacle lenses will be evaluated at each specified timepoint.
4 days and 2 weeks post-dispensing
High-contrast visual acuity (distance and near)
Tijdsspanne: At dispensing (baseline) and 2 weeks post-dispensing
Monocular and binocular high-contrast visual acuity at distance and near, measured while wearing study spectacles, will be compared between the test and control groups.
At dispensing (baseline) and 2 weeks post-dispensing

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Essilor International

Onderzoekers

  • Hoofdonderzoeker: Sheron Quak, Essilor R&D Centre Singapore

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juni 2026

Primaire voltooiing (Geschat)

1 oktober 2026

Studie voltooiing (Geschat)

1 november 2026

Studieregistratiedata

Eerst ingediend

17 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

2 juli 2026

Eerst geplaatst (Werkelijk)

6 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

6 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

2 juli 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • WS10506
  • PIEC/2026/015 (Register-ID: Parkway Independent Ethics Committee)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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