Choroidal Response to the Modified Defocus Incorporated Multiple Segments Spectacle Lenses

Sponsor
The Hong Kong Polytechnic University
Study ID
NCT07547072
Status
Not Yet Recruiting

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Conditions

  • Myopia

Eligibility Criteria

Sex
ALL
Age
6 Years - 13 Years
Healthy Volunteers
Accepted

Interventions

  • Modified Defocus Incorporated Multiple Segments lens (D1) — OTHER
    D1 is a modified Defocus Incorporated Multiple Segments lens that corrects the distance refraction and provides myopic defocus simultaneously
  • Modified Defocus Incorporated Multiple Segments lens (D2) — OTHER
    D2 is a modified Defocus Incorporated Multiple Segments lens that corrects the distance refraction and provides myopic defocus simultaneously

Study Details

The goal of this study is to investigate the short-term changes in choroidal thickness and efficacy of the study spectacle lenses in children. Participants will be prescribed with a pair of study spectacle lenses for daily use and visit the clinic once every week for the first month for checkup and tests. After the first month of follow-up, participants will visit at 1 month, 6- and 12-month for checkup. Choroidal thickness, axial length and refractive errors will be monitored.

Key Dates

First listed
Apr 23, 2026
Start date
Apr 25, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Feb 29, 2028

Study Design

Enrollment
108 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Single vision lens group
    Participants in single vision lens group will receive a pair of single vision lenses for 1 year after the short-term monitoring of choroidal thickness.
  • Experimental: D1 lens group
    Participants in D1 lens group will receive a pair of D1 lenses over 1 year after the short-term monitoring of choroidal thickness.
  • Experimental: D2 lens group
    Participants in D2 lens group will receive a pair of D2 lenses over 1 year after the short-term monitoring of choroidal thickness.

Primary Outcome Measure

Choroidal thickness changes [ Time Frame: Baseline, every week for 1 month, every 6 months over 1 year ]

Central Contacts

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