Myopia, Myopia Progression
Conditions
Keywords
Myopia, Spectacles, Glasses, Myopia Control, Pediatric, DIMS
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.
Interventions
DEVICEEYE001
Defocus incorporated multiple segments (DIMS) clear vs DIMS photochromic
Sponsors
Singapore National Eye Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
6 Years to 15 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparing photochromic DIMS spectacles lenses performance (PDIMS) versus clear DIMS spectacles lenses (DIMS) | 24 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Performance of photochromic DIMS spectacles lenses performance (PDIMS) compared to clear DIMS spectacles lenses (DIMS) | 24 months | To assess the safety, tolerability (quality of life (QoL)), and adaptation to PDIMS lens wear compared to DIMS lens wear. |
Countries
Singapore
Contacts
Primary ContactBryan Sim, MD FRCOphth (UK)
Outcome results
None listed