Clincosm LogoSign in Get a demo

Effectiveness of the Defocus Incorporated Spectacle Lenses on Fast Progressing Myope - Auxiliary Group

Sponsor
The Hong Kong Polytechnic University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05888805
Collaborator
HOYA Lens Thailand LTD. (Industry)
59
Enrollment
1
Location
1
Arm
36
Anticipated Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to examine the efficacy and performance of the Defocus Incorporated Multiple Segments (DIMS) Spectacle lenses on controlling myopia progression in fast progressing myopic children.

Condition or Disease Intervention/Treatment Phase
  • Other: DIMS spectacle lens
 N/A

Detailed Description

DIMS spectacle lens is a multifocal spectacle lens that produces myopic defocus images and corrects distance refractive errors at the same time.

Participants will be prescribed a pair of DIMS spectacle lenses. Their cycloplegic refraction and axial length will be monitored every 6 months over 2 years.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
59 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Participants will be prescribed with a pair of DIMS spectacle lenses for 24 months.Participants will be prescribed with a pair of DIMS spectacle lenses for 24 months.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effectiveness of the Defocus Incorporated Spectacle Lenses on Fast Progressing Myope - Auxiliary Group
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Feb 28, 2026
Anticipated Study Completion Date :
May 31, 2026

Arms and Interventions

Arm Intervention/Treatment
Other: DIMS lens group

Participants will be prescribed with a pair of DIMS spectacle lenses for 24 months.

Other: DIMS spectacle lens
DIMS spectacle lens is a multifocal spectacle lens that corrects the distance refraction and provides myopic defocus simultaneously.
Other Names:
  • MiYOSMART

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Cycloplegic refraction change in spherical equivalent refraction (SER) [Baseline, 1st year and 2nd year]

      Cycloplegic SER (in diopter) will be measured using an open field autorefractor. Change in SER with cycloplegia from the baseline over a first 12-month period and a 12-month period of follow-up will be measured.

    Secondary Outcome Measures

    1. Axial length change [Baseline, 1st year and 2nd year]

      Axial length (mm) will be measured after cycloplegia using a non-contact optical biometer. Change in axial length from the baseline over a first 12-month period and a 12-month period of follow-up will be measured.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • SER: -1.00D or below

    • Documented history of fast progressing myopia, either in SER or AL

    • SER progression: 0.50D/year or more

    • AL elongation: 0.27mm/year or more

    • Best-corrected monocular visual acuity (VA) in both eyes: 0.00 logMAR (equivalent) or better

    • Acceptance of random group allocation and the masked study design

    • Anisometropia of 1.50 D or less

    • Astigmatism of 2.00 D or less

    Exclusion Criteria:

    • Strabismus and binocular vision abnormalities

    • Ocular and systemic abnormalities

    • Prior experience of myopia control

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 School of Optometry, The Hong Kong Polytechnic University Hung Hom Hong Kong

    Sponsors and Collaborators

    • The Hong Kong Polytechnic University
    • HOYA Lens Thailand LTD.

    Investigators

    • Principal Investigator: Dennis Yan Yin Tse, PhD, School of Optometry, The Hong Kong Polytechnic University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The Hong Kong Polytechnic University
    ClinicalTrials.gov Identifier:
    NCT05888805
    Other Study ID Numbers:
    • P0043588
    First Posted:
    Jun 5, 2023
    Last Update Posted:
    Jun 5, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by The Hong Kong Polytechnic University
    Myopia
    Defocus
    Additional relevant MeSH terms:
    Myopia

    Study Results

    No Results Posted as of Jun 5, 2023