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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Myopia
• Intervention / Treatment: Device: Model-A Novel spectacle lens; Device: Model-B Novel spectacle lens; Device: Single vision spectacle lens

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 249
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Model-A Novel Spectacle lens	Device: Model-A Novel spectacle lens; Model-A Novel spectacle lenses will be given to 1 arm to wear for 36 months
Experimental: Model-B Novel Spectacle lens	Device: Model-B Novel spectacle lens; Model-B Novel spectacle lenses will be given to 1 arm to wear for 36 months
Other: Single Vision Spectacle lens	Device: Single vision spectacle lens; Single Vision Spectacle lenses will be given to 1 arm to wear for 36 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Axial length	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	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

Secondary Outcome Measures

Outcome Measure	Time Frame
Axial length	36 months
Spherical equivalent cycloplegic autorefraction	36 months

Collaborators and Investigators

• Sponsor: HOYA Lens Thailand LTD.
• Investigators: Study Chair: William Zhou, MD, HOYA Lens Thailand LTD.

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: May 23, 2023
• First Submitted That Met QC Criteria: May 23, 2023
• First Posted (Actual): June 2, 2023

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: DG2-3A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No