🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT05886348
Active, not recruiting Not applicable

The Evaluation of Safety and Myopia Progression Control Using Novel Spectacle Lens

NCT05886348 · tracked via the Priya Life Science China tracker
Sponsor
HOYA Lens Thailand LTD.
Phase
Not applicable
Started
2023-07-31
Last updated
2026-09-18

Condition(s) studied

Myopia

Investigational drug(s) / intervention(s)

Model-A Novel spectacle lensModel-B Novel spectacle lensSingle vision spectacle lens

Model-A Novel spectacle lens: Model-A Novel spectacle lenses will be given to 1 arm to wear for 36 months

Model-B Novel spectacle lens: Model-B Novel spectacle lenses will be given to 1 arm to wear for 36 months

Single vision spectacle lens: Single Vision Spectacle lenses will be given to 1 arm to wear for 36 months

Study summary

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.

Eligibility

Sex
ALL
Min age
7 Years
Max age
13 Years
Healthy volunteers
Accepted
Inclusion Criteria: 1. Participant and parent (or guardian) are able and willing to provide consent 2. Participant and parent (or guardian) ensure to attend required study visits and adhere to participant requirements 3. 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 4. Participant willing to wear the study spectacles lens for a minimum of 12 hours per day for the duration of the study 5. Age at time of parent or guardian consent and participant assent: 7 - 13 years old 6. Spherical equivalent cycloplegic autorefraction: -1.00 to -7.00 D in each eye. 7. Cycloplegic autorefraction astigmatism of 1.50 D or less in each eye 8. Cycloplegic autorefraction anisometropia of 1.50 D or less 9. Monocular best corrected distance visual acuity (BCDVA) equal to or better than logMAR 0.10 in each eye. Exclusion Criteria: 1. Participant is allergy to fluorescein, benoxinate, proparacaine, tropicamide or cyclopentolate eye drops 2. Any ocular and systemic abnormalities might be expected to affect visual functions or refractive development 3. (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. 4. Participant with clinically significant strabismus (including intermittent tropia) 5. Medical history of binocular vision abnormalities 6. Participant with amblyopia 7. Participation in a clinical trial within 30 days prior to entry into this study or during participation 8. Previous intraocular surgery 9. 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. 10. Any medical treatment or medication which might have an influence on vision or interfere with study assessments 11. 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)

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
Beijing Tongren Hospital, Capital Medical University Beijing China
Guangzhou Aier Eye Hospital Guangzhou China
Eye and ENT Hospital of Fudan University Shanghai China
Shengyang He Eye Specialist Hospital Shengyang China
Tianjin Medical University Eye Hospital Tianjin China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05886348 on ClinicalTrials.gov ↗ ← All trials in China