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

November 29, 2024 updated by: Bryan Sim XR, Singapore National Eye Centre

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

202

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Singapore
      • Singapore, Singapore, 159029
        • Singapore National Eye Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Device: EYE001
Defocus incorporated multiple segments (DIMS) clear vs DIMS photochromic
Other Names:
  • Defocus incorporated multiple segments (DIMS) lenses
Active Comparator: 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.
Device: EYE001
Defocus incorporated multiple segments (DIMS) clear vs DIMS photochromic
Other Names:
  • Defocus incorporated multiple segments (DIMS) lenses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparing photochromic DIMS spectacles lenses performance (PDIMS) versus clear DIMS spectacles lenses (DIMS)
Time Frame: 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).
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance of photochromic DIMS spectacles lenses performance (PDIMS) compared to clear DIMS spectacles lenses (DIMS)
Time Frame: 24 months
To assess the safety, tolerability (quality of life (QoL)), and adaptation to PDIMS lens wear compared to DIMS lens wear.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Singapore National Eye Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 2, 2025

Primary Completion (Estimated)

January 2, 2027

Study Completion (Estimated)

January 2, 2027

Study Registration Dates

First Submitted

November 23, 2024

First Submitted That Met QC Criteria

November 29, 2024

First Posted (Estimated)

December 4, 2024

Study Record Updates

Last Update Posted (Estimated)

December 4, 2024

Last Update Submitted That Met QC Criteria

November 29, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SingaporeNEC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Change in spherical equivalent and axial length over time for further trials in future

IPD Sharing Time Frame

2025-2026

IPD Sharing Access Criteria

Interested investigators

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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