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

NCT ID: NCT06717035

Last Updated: 2024-12-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-02
• Study Completion Date: 2027-01-02

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.

Detailed Description

Myopia now is recognized as one of the important public health problems and myopia prevention and control has become more important. Various myopia management strategies have been tested in the past for the control of myopia progression in children. In recent years, various optical interventions have also been explored to manage myopia, including the use of optical, pharmaceutical, and lifestyle interventions. Spectacles, atropine eye drops, and outdoor activities have shown some efficacy in slowing myopia progression, but the optimal approach to delaying or preventing the onset of myopia in at-risk populations remains a challenge. These myopia management modalities are often also labelled as invasive and non-invasive methods. One of the non-invasive myopia management modalities includes spectacles.

DIMS spectacle lenses are based on creating myopic defocus at the mid-periphery of the retina which would provide a cue of axial length elongation control. DIMS is a spectacle lens with a central optical zone of 9.4 mm for correcting distance myopic refractive errors and a mid-peripheral 33mm of treatment zone with multiple segments of 1 mm diameter, each segment provides defocus of + 3.5D. 2-year Randomised Controlled Trial (RCT) showed 52% reduction in myopia progression and 62% slow down effect in axial elongation in children wearing DIMS spectacle lenses compared to those on single vision spectacle lens correction at the end of 2-year follow-up in Hong Kong children.

2-years RCT has been conducted using DIMS clear spectacle lenses, however, no studies have been conducted on photochromic and polarized version to show the non-inferiority of sun solutions compared to clear version in myopia management.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Children on clear DIMS lenses

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.

Group Type: ACTIVE_COMPARATOR

EYE001

Intervention Type: DEVICE

Defocus incorporated multiple segments (DIMS) clear vs DIMS photochromic

Children on photochromic DIMS lenses

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.

Group Type: ACTIVE_COMPARATOR

EYE001

Intervention Type: DEVICE

Defocus incorporated multiple segments (DIMS) clear vs DIMS photochromic

Interventions

EYE001

Defocus incorporated multiple segments (DIMS) clear vs DIMS photochromic

Intervention Type: DEVICE

Other Intervention Names

Defocus incorporated multiple segments (DIMS) lenses

Eligibility Criteria

Inclusion Criteria

Subjects must meet all the criteria listed to participate in the study:

1. All ethnicities

2. Age between 6 and 15 years

3. Refraction -0.50D till - 7.00D and astigmatism ≤ 3.00D

4. Anisometropia ≤ 3.00D

5. Best corrected monocular distance high contrast VA ≤ 0.10 logMAR

6. Normal Binocular vision (fusion and stereopsis)

9. No informed consent given by parents of child for participation in the clinical study

10. Subject is allergic to cycloplegic eye drops

Exclusion Criteria

1. Ocular and systemic abnormalities

2. Children who do not cooperate

3. Binocular vision anomalies (strabismus, suppression)

4. Previous use of myopia management treatment (spectacles, atropine, CLs)

5. Neurological disorders

6. Premature infants

7. Children who do not wear their glasses correctly for intermediate and near vision activities

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Singapore National Eye Centre

OTHER_GOV

Sponsor Role: lead

Responsible Party

Bryan Sim XR

Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Singapore National Eye Centre

Singapore, , Singapore

Countries

Singapore

Central Contacts

Bryan Sim, MD FRCOphth (UK)

Role: CONTACT

Phone: +6597722192

Email: bryansimxr@hotmail.com

Facility Contacts

Bryan Sim, MBBS FRCOphth

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 33731364 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31142465 (View on PubMed)

Other Identifiers

SingaporeNEC

Identifier Type: -

Identifier Source: org_study_id