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

Singapore National Eye Centre

Status: Not yet enrolling

Conditions: Myopia; Myopia Progression

Treatments: Device: EYE001

Study type: Interventional

Funder types: Other

Identifiers

NCT06717035

SingaporeNEC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 202 estimated patients

Sex: All

Ages: 6 to 15 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Exclusion Criteria

All subjects meeting any of the exclusion criteria at baseline will be excluded from participation:

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
8. Children who do not meet the inclusion criteria
9. No informed consent given by parents of child for participation in the clinical study
10. Subject is allergic to cycloplegic eye drops

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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202 participants in 2 patient groups

Children on clear DIMS lenses

Active Comparator group

Description:

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.

Treatment:

Device: EYE001

Children on photochromic DIMS lenses

Active Comparator group

Description:

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.

Treatment:

Device: EYE001