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

Not Applicable

Active, not recruiting

• Conditions: Myopia
• Interventions: Device: Model-B Novel spectacle lens; Device: Model-A Novel spectacle lens; Device: Single vision spectacle lens

• Registration Number: NCT05886348
• Lead Sponsor: HOYA Lens Thailand LTD.

Brief 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.

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 Timeline

• Study First Submitted: 2023-05-23
• Study First Submitted QC: 2023-05-23
• Study First Posted: 2023-06-02
• Study Start: 2023-07-31
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-23
• Last Update Posted: 2024-07-24
• Primary Completion: 2026-05-31
• Study Completion: 2027-05-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 249

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 0.00 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Model-B Novel Spectacle lens	Model-B Novel spectacle lens	-
Model-A Novel Spectacle lens	Model-A Novel spectacle lens	-
Single Vision Spectacle lens	Single vision spectacle lens	-

Primary Outcome Measures

Name	Time	Method
Axial length	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.
Spherical equivalent cycloplegic autorefraction	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

Secondary Outcome Measures

Name	Time	Method
Axial length	36 months
Spherical equivalent cycloplegic autorefraction	36 months

Trial Locations

Locations (5)

Beijing Tongren Hospital, Capital Medical University; 🇨🇳 Beijing, China

Guangzhou Aier Eye Hospital; 🇨🇳 Guangzhou, China

Eye and ENT Hospital of Fudan University; 🇨🇳 Shanghai, China

Tianjin Medical University Eye Hospital; 🇨🇳 Tianjin, China

Shengyang He Eye Specialist Hospital; 🇨🇳 Shengyang, China