- ICH GCP
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- Klinische proef NCT05886348
De evaluatie van veiligheid en progressiecontrole bijziendheid met behulp van een nieuwe brillenlens
The goal of this clinical trial is to test Novel spectacle lenses in myopic children. The main question it aims to answer are: safety and efficacy of the lenses. Participants will be asked to wear spectacles and participate in eye exams and questionnaires. Researchers will compare Novel spectacle lenses and general single vision spectacle lenses to see if the Novel spectacle lenses correct myopic ametropia, slow the progression of myopia and axial elongation.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
This is a 3-year prospective, multicenter, randomized, and single-masked*, parallel-group controlled clinical study. The purpose of this study is to evaluate the safety and efficacy of wearing Novel spectacle lenses to correct myopic ametropia, slow the progression of myopia and axial elongation in myopic children as compared to the use of single vision spectacles lenses.
The treatment arms are:
- Model A Novel spectacle lens
- Model B Novel spectacle lens
- Single vision spectacle lens
Single-masked:
The investigator responsible for conducting ocular data measurements related to the primary and secondary endpoints will be masked. The participants will not be informed the treatment arm during the clinical trial.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
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Beijing, China
- Beijing Tongren Hospital, Capital Medical University
-
Guangzhou, China
- Guangzhou Aier Eye Hospital
-
Shanghai, China
- Eye and ENT Hospital of Fudan University
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Shengyang, China
- Shengyang He Eye Specialist Hospital
-
Tianjin, China
- Tianjin Medical University Eye Hospital
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-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Participant and parent (or guardian) are able and willing to provide consent
- Participant and parent (or guardian) ensure to attend required study visits and adhere to participant requirements
- Parent or guardian understands and accepts random allocation of grouping, and that participant and parent (or guardian) will not be told which group participant is allocated to
- Participant willing to wear the study spectacles lens for a minimum of 12 hours per day for the duration of the study
- Age at time of parent or guardian consent and participant assent: 7 - 13 years old
- Spherical equivalent cycloplegic autorefraction: -1.00 to -7.00 D in each eye.
- Cycloplegic autorefraction astigmatism of 1.50 D or less in each eye
- Cycloplegic autorefraction anisometropia of 1.50 D or less
- Monocular best corrected distance visual acuity (BCDVA) equal to or better than logMAR 0.10 in each eye.
Exclusion Criteria:
- Participant is allergy to fluorescein, benoxinate, proparacaine, tropicamide or cyclopentolate eye drops
- Any ocular and systemic abnormalities might be expected to affect visual functions or refractive development
- (a) Have received treatment of myopic control pharmaceutical medication (e.g., atropine) or light fundus illuminance therapy (e.g., repeated red light therapy) within 6 months prior to entry into this study. (b) Have received treatment of myopia control such as contact lenses, orthokeratology lenses etc., progressive addition lenses, bifocal lenses, within 3 months. (c) Have received treatment of myopia control such as defocus spectacle lenses (difference between both eye's non-cycloplegic autorefraction and lens-meter results of the respective lenses are equal or less than 0.50 D SER) etc. within one month prior to entry into this study.
- Participant with clinically significant strabismus (including intermittent tropia)
- Medical history of binocular vision abnormalities
- Participant with amblyopia
- Participation in a clinical trial within 30 days prior to entry into this study or during participation
- Previous intraocular surgery
- Participant who, in the judgment of the Investigator, presence of any emotional, physiologic, or anatomical condition which may preclude participation in this study or provide an inappropriate landscape for the intended study treatment.
- Any medical treatment or medication which might have an influence on vision or interfere with study assessments
- Pathological myopia (myopia that leads to structural changes in the posterior segment of the eye including posterior staphyloma, myopic maculopathy, and high myopia-associated optic neuropathy)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Model-A Nieuwe brillens
|
Model-A Novel spectacle lenses will be given to 1 arm to wear for 36 months |
|
Experimenteel: Model-B Nieuwe brillens
|
Model-B Novel spectacle lenses will be given to 1 arm to wear for 36 months |
|
Ander: Enkelvoudige brillenglazen
|
Single Vision Spectacle lenses will be given to 1 arm to wear for 36 months |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Axial length
Tijdsspanne: 24 months
|
The difference of Axial length changes over 24 months between treatment groups in low and moderate myopia (-1.00 D to -5.00 D) participants. |
24 months
|
|
Spherical equivalent cycloplegic autorefraction
Tijdsspanne: 24 months
|
The difference of spherical equivalent cycloplegic autorefraction changes over 24 months between treatment groups in low and moderate myopia (-1.00 D to -5.00 D) participants |
24 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Axiale lengte
Tijdsspanne: 36 maanden
|
36 maanden
|
|
Sferische equivalente cycloplegische autorefractie
Tijdsspanne: 36 maanden
|
36 maanden
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
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
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- DG2-3A
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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