- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07839091
Comparing Myopia Control Spectacle Lenses and Standard Single Vision Spectacle Lenses in Children With Myopia (PEARL)
A Paired-Eye Comparison of Myopia Control Lenses in Myopic Children
The purpose of this clinical trial is to compare a new myopia control spectacle lens with a standard single vision spectacle lens in slowing the progression of myopia (nearsightedness) in healthy children aged 6 to under 11 years.
The main question being studied is:
Is the new myopia control spectacle lens more effective than a standard single vision spectacle lens in slowing myopia progression?
In this study, participants will wear a myopia control spectacle lens in one eye and a standard single vision spectacle lens in the other eye for the first 6 months. The lens assignment will then be switched between eyes for the remaining 6 months. Researchers will compare changes in eye axial length and refractive error between the two lens types.
Participants will:
- Wear the study spectacles for 12 months.
- Attend scheduled follow-up visits at the Essilor R&D Centre, Singapore.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Thomas Boudenne
- E-Mail: thomas.boudenne@essilor.com
Studieren Sie die Kontaktsicherung
- Name: Celine Carimalo
- Telefonnummer: +65 67134617
- E-Mail: carimalc@essilor.com.sg
Studienorte
-
-
-
Singapore, Singapur
- Essilor R&D Centre Singapore
-
Kontakt:
- Celine Carimalo
- Telefonnummer: +65 67134617
- E-Mail: carimalc@essilor.com.sg
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Volunteer participant with the willingness and ability to comply with all scheduled study visits.
- Informed consent of parent/guardian and assent of participant.
- Age equal to or greater than 6 years and less than 11 years (before 11th birthday) at the time of consent.
- Spherical equivalent refraction (SER) equal or less than -0.50 D and equal or greater than -4.75D with astigmatism not more than 2.00 D.
- Difference in SER (anisometropia) between two eyes should not exceed 1.00 D.
- Best corrected Distance Visual Acuity (BCDVA) better than or equal to +0.10 LogMAR under high contrast in each eye.
- Be in good general health, based on the participant and the parent's/guardian's knowledge.
- Agree to wear the study spectacles for 12 hours per day and 7 days per week.
- Agree not to be involved in other myopia control treatments.
Exclusion Criteria:
- History of Atropine, Orthokeratology, Myopia Control 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.
- Current or anticipated use of growth hormones.
- 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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: OD: SVL; OS: MCL then OD: MCL; OS: SVL
Participants will wear the investigational myopia control spectacle lens in the left eye and a standard single vision spectacle lens in the right eye for the first 6 months. After 6 months, the lens assignment will be switched, with each eye wearing the opposite lens type for another 6 months. |
A spectacle lens designed to help slow the progression of myopia in children A standard spectacle lens used to correct refractive error without a specific myopia control feature |
|
Experimental: OD: MCL; OS: SVL then OD: SVL; OS: MCL
Participants will wear the investigational myopia control spectacle lens in the right eye and a standard single vision spectacle lens in the left eye for the first 6 months. After 6 months, the lens assignment will be switched, with each eye wearing the opposite lens type for another 6 months. |
A spectacle lens designed to help slow the progression of myopia in children A standard spectacle lens used to correct refractive error without a specific myopia control feature |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Change in Eye Axial Length
Zeitfenster: From baseline to 6 months
|
From baseline to 6 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Change in Eye Axial Length
Zeitfenster: From 6 months to 12 months
|
From 6 months to 12 months
|
|
Change in Eye Non-Cycloplegic Spherical Equivalent Refraction
Zeitfenster: From baseline to 6 months
|
From baseline to 6 months
|
|
Change in Eye Non-Cycloplegic Spherical Equivalent Refraction
Zeitfenster: From 6 months to 12 months
|
From 6 months to 12 months
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Andrew Tan, Essilor R&D Centre Singapore
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- WS10528
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .