Effect of a Myopia Control Lens on the Astigmatism in Children (MAC)
A Monocentre, Single-Arm Trial to Study the Effect of Lens Inspired by Myopia Control Solutions on the Astigmatism of a Child
The goal of this clinical trial is to investigate over a one-year period the effect of myopia control spectacle lenses on astigmatism in children aged 6 to 13 years with myopia and astigmatism.
The main question it aims to answer is:
- How does the eye respond at each timepoint to the myopia control lenses?
By evaluating: the change in astigmatism (cylinder) after one year?
Participants will:
Wear the assigned study spectacles daily
Visit the Essilor R&D Centre for scheduled follow-up sessions
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Thomas Boudenne
- E-mail: thomas.boudenne@essilor.com
Studie Contact Back-up
- Naam: Celine Carimalo
- Telefoonnummer: +65 67134600
- E-mail: carimalc@essilor.com.sg
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- Volunteer participant
- Informed consent of parent or guardian and assent of participant
- Age equal to or greater than 6 years and less than 13 years (before 13th birthday) at the time of consent.
Refractive error (manifest refraction):
- With the rule astigmatism (defined as vertical meridian has steeper curvature, Astigmatism prescribing axis in between: 0 to 34° and 146 to 180°)
- Astigmatism should be more than or equal to 1.50D
- Least myopic meridian equal or less than -0.50D
- Most myopic meridian equal or greater than -5.50D.
- Anisometropia should be less than or equal to 1.00D
- Best corrected visual acuity: Better than 0.2 logMAR in each eye
Willingness and ability to:
- participate in trial for at least 12 months.
- attend scheduled visits.
- not to be involved in other myopia control treatments concurrently.
- No history of any myopia control interventions (i.e., myopia control spectacle lenses, myopia control contact lenses, orthokeratology lenses or atropine, etc.)
Exclusion Criteria:
History or presence of:
- An ocular disease
- Strabismus
- Amblyopia
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Myopia Control Lens Prototype
Each participant will be fitted with a prototype lenslet-based spectacle lens to be worn continuously throughout the 12-month study period. Following the baseline and dispensing visit, participants will undergo follow-up assessments at 3, 6, and 12 months. These intervals will monitor change of myopia and astigmatism through standard refraction and ocular biometry measurements. Device Details: The myopia control spectacle lens utilized in this study features a lenslet-based design (incorporating a highly aspherical lenslet configuration). The lenses will be dispensed and worn daily for the duration of the 12-month evaluation period. |
Device Details: The myopia control spectacle lens utilized in this study features a lenslet-based design (incorporating a highly aspherical lenslet configuration). In this specific device, the lenslet are located in concentric rings. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Change from baseline in the Cylinder value through non cycloplegic autorefraction
Tijdsspanne: 12 months
|
12 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change from baseline in the Keratometry value measured using a Keratometer
Tijdsspanne: 12 months
|
12 months
|
|
|
Change from baseline in the Axial Length value measured using a biometer
Tijdsspanne: 12 months
|
12 months
|
|
|
Quality of Life while wearing the study lenses measured through Questionnaire
Tijdsspanne: Baseline, 6 and 12 months
|
PREP 2 questionnaire: Pediatric Refractive Error Profile 2 The questionnaire is designed to assess the vision-specific quality of life in children who wear glasses or contact lenses. It covers seven areas: Vision, Symptoms, Handling, Peer Perception, Activities, Appearance, and Overall. The Child form is a 5 point agreement scale ranging from: Strongly Disagree, Disagree, Neutral, Agree, Strongly Agree The parent form is a 10 point agreement scale ranging from 1=likes and 10=dislikes |
Baseline, 6 and 12 months
|
Andere uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Safety: Change from baseline in the Axial Length value measured using a biometer
Tijdsspanne: 3 and 6 months
|
3 and 6 months
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Si Ying Lim, EssilorLuxottica
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- WS10487
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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