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

NCT05886348 | Active Not Recruiting

• 1 other identifier: DG2-3A
• Study Type: interventional
• Target: 249
• Locations: 1 country
• Sites: 5

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.

Conditions

Myopia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Axial length

  36 months

• Spherical equivalent cycloplegic autorefraction

  36 months

Study Arms (3)

Model-A Novel Spectacle lens

EXPERIMENTAL

Device: Model-A Novel spectacle lens

Model-B Novel Spectacle lens

EXPERIMENTAL

Device: Model-B Novel spectacle lens

Single Vision Spectacle lens

OTHER

Device: Single vision spectacle lens

Interventions

Model-A Novel spectacle lens DEVICE

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

Model-A Novel Spectacle lens

Model-B Novel spectacle lens DEVICE

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

Model-B Novel Spectacle lens

Single vision spectacle lens DEVICE

Single Vision Spectacle lenses will be given to 1 arm to wear for 36 months

Single Vision Spectacle lens

Eligibility Criteria

• Age: 7 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• HOYA Lens Thailand LTD.: lead

Study Sites (5)

Beijing Tongren Hospital, Capital Medical University

Beijing, China

Location

Guangzhou Aier Eye Hospital

Guangzhou, China

Location

Eye and ENT Hospital of Fudan University

Shanghai, China

Location

Shengyang He Eye Specialist Hospital

Shengyang, China

Location

Tianjin Medical University Eye Hospital

Tianjin, China

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: June 2, 2023
• Study Start: July 31, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

CN (5)