Evaluation of Performance of MiYOSMART Photochromic and Clear Spectacle Lenses in Myopic Children

NCT06717035 | Not Yet Recruiting DMC

• 1 other identifier: SingaporeNEC
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study aims to evaluate the non-inferiority of the photochromic DIMS spectacles lenses performance (PDIMS) compared to clear DIMS spectacles lenses (DIMS) in myopia management.

Conditions

Myopia; Myopia Progression

Keywords

Myopia; Spectacles; Glasses; Myopia Control; Pediatric; DIMS

Outcome Measures

Primary Outcomes (1)

• Comparing photochromic DIMS spectacles lenses performance (PDIMS) versus clear DIMS spectacles lenses (DIMS)

  The primary objective of this study is to evaluate the efficacy of photochromic DIMS spectacles lenses performance (PDIMS) compared to clear DIMS spectacles lenses (DIMS) in terms of childhood myopia control (cycloplegic spherical equivalent refraction (SER), axial elongation and choroidal thickness).

  24 months

Secondary Outcomes (1)

• Performance of photochromic DIMS spectacles lenses performance (PDIMS) compared to clear DIMS spectacles lenses (DIMS)

  24 months

Study Arms (2)

Children on clear DIMS lenses

ACTIVE COMPARATOR

202 children will be recruited at 6 institutions following the rules of inclusion and exclusion criteria. Based on a randomization process defined from the study coordinator, children will be allocated to 2 groups: DIMS and PDIMS. The study will be single blinded, meaning that the investigators are not aware of which type of treatment will be associated with which subjects. Subjects cannot be blinded due to the darkening of PDIMS that allows recognition on the type of lens.

Device: EYE001

Children on photochromic DIMS lenses

ACTIVE COMPARATOR

202 children will be recruited at 6 institutions following the rules of inclusion and exclusion criteria. Based on a randomization process defined from the study coordinator, children will be allocated to 2 groups: DIMS and PDIMS. The study will be single blinded, meaning that the investigators are not aware of which type of treatment will be associated with which subjects. Subjects cannot be blinded due to the darkening of PDIMS that allows recognition on the type of lens.

Device: EYE001

Interventions

EYE001 DEVICE

Defocus incorporated multiple segments (DIMS) clear vs DIMS photochromic

Also known as: Defocus incorporated multiple segments (DIMS) lenses

Children on clear DIMS lenses; Children on photochromic DIMS lenses

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Subjects must meet all the criteria listed to participate in the study:
• All ethnicities
• Age between 6 and 15 years
• Refraction -0.50D till - 7.00D and astigmatism ≤ 3.00D
• Anisometropia ≤ 3.00D
• Best corrected monocular distance high contrast VA ≤ 0.10 logMAR
• Normal Binocular vision (fusion and stereopsis)

You may not qualify if:

• Ocular and systemic abnormalities
• Children who do not cooperate
• Binocular vision anomalies (strabismus, suppression)
• Previous use of myopia management treatment (spectacles, atropine, CLs)
• Neurological disorders
• Premature infants
• Children who do not wear their glasses correctly for intermediate and near vision activities
• No informed consent given by parents of child for participation in the clinical study
• Subject is allergic to cycloplegic eye drops

Sponsors & Collaborators

• Singapore National Eye Centre: lead

Study Sites (1)

Singapore National Eye Centre

Singapore, 159029, Singapore

Location

Related Publications (2)

• Lam CS, Tang WC, Lee PH, Zhang HY, Qi H, Hasegawa K, To CH. Myopia control effect of defocus incorporated multiple segments (DIMS) spectacle lens in Chinese children: results of a 3-year follow-up study. Br J Ophthalmol. 2022 Aug;106(8):1110-1114. doi: 10.1136/bjophthalmol-2020-317664. Epub 2021 Mar 17.

  PMID: 33731364 BACKGROUND

• Lam CSY, Tang WC, Tse DY, Lee RPK, Chun RKM, Hasegawa K, Qi H, Hatanaka T, To CH. Defocus Incorporated Multiple Segments (DIMS) spectacle lenses slow myopia progression: a 2-year randomised clinical trial. Br J Ophthalmol. 2020 Mar;104(3):363-368. doi: 10.1136/bjophthalmol-2018-313739. Epub 2019 May 29.

  PMID: 31142465 BACKGROUND

MeSH Terms

Conditions

Myopia

Interventions

Lenses

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies

Central Study Contacts

Bryan Sim, MD FRCOphth (UK)

CONTACT

+6597722192; bryansimxr@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Model Details: Randomization: 202 children will be recruited at 6 institutions following the rules of inclusion and exclusion criteria. Based on a randomization process defined from the study coordinator, children will be allocated to 2 groups: DIMS and PDIMS. The study will be single blinded, meaning that the investigators are not aware of which type of treatment will be associated with which subjects. Subjects cannot be blinded due to the darkening of PDIMS that allows recognition on the type of lens.

Study Record Dates

• First Submitted: November 23, 2024
• First Posted: December 4, 2024
• Study Start: January 2, 2025
• Primary Completion (Estimated): January 2, 2027
• Study Completion (Estimated): January 2, 2027
• Last Updated: December 4, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 2025-2026
• Access Criteria: Interested investigators

Locations

SG (1)