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RecruitingNCT07547072Updated Sep 17, 2026

Choroidal Response to the Modified Defocus Incorporated Multiple Segments Spectacle Lenses

An interventional study of Modified Defocus Incorporated Multiple Segments lens (D1) and Modified Defocus Incorporated Multiple Segments lens (D2) in Myopia, sponsored by The Hong Kong Polytechnic University. Recruiting at 1 site in Hong Kong. Open to participants aged 6 Years to 13 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2026; still recruiting 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
108
Allocation
Randomized
Ages
6 Years to 13 Years
Sex
All
01

Study summary

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.

Read the detailed description

Optical interventions have been widely used for myopia control in children, however, the effectiveness varied between individuals. The current study spectacle lenses are modified based on DIMS technology.

Participants will be randomly allocated to single vision (SV) lens group (control), D1 or D2 group (treatment). The weekly choroidal thickness changes will be monitored in the first month of lens wear. Their cycloplegic refraction and axial length will be monitored every 6 months for 1 year.

02

Conditions studied

  • Myopia

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Keywords

  • Myopia
  • Choroidal thickness
03

In context

Myopia

1,159 studies on the registry are indexed under Myopia; 225 are open to participants now.

This study's planned enrollment of 108 is above the median of 78 across 923 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

The Hong Kong Polytechnic University is the lead sponsor of 679 studies on the registry; 257 are open to participants now.

Browse The Hong Kong Polytechnic University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 13 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Hong Kong Chinese
  • Age at enrolment: 6 - 13 years
  • Myopia in spherical power: -1.00D to -5.00D in both eyes
  • Astigmatism: equal or less than 2.00D
  • The sum of spherical power and astigmatism: equal or less than -7.00D
  • Anisometropia (spherical equivalent refraction (SER)): equal or less than 1.50D

  • Previous myopia progression (valid documentation dated within 2 years before screening):

    • -0.50D (SER) per year or more in both eyes OR Axial length elongation: 0.27mm/year in both eyes
    • If myopia is initially detected during screening, eligibility requires myopia (in SER) below the 3rd percentile curve of refraction in both eyes.12
  • Best corrected visual acuity: LogMAR 0.04 or better in both eyes
  • Ocular health: no abnormalities in both internal and external ocular health
  • Binocular vision: no strabismus and other binocular abnormalities
  • Normal colour vision
  • Willing to wear the study spectacles all the time (10 hours per day, for 7 days per week)

Exclusion criteria

Exclusion Criteria:

  • Previous or current treatment for myopia control (e.g., red-light therapy, atropine, orthokeratology, specialized spectacle lenses and contact lenses and oral supplements for myopic control)
  • Existing or past eye diseases or surgeries (e.g., strabismus surgery, amblyopia, oculomotor nerve palsies, corneal disease, intraocular disease, etc.) that may have an impact on vision or visual development
  • Long-term medication (intake at least 3 days/week) or medication/supplements that affect eye health
  • Systemic diseases that may have an impact on vision or visual development (e.g., endocrine, cardiac and respiratory diseases, diabetes, Down syndrome, etc.)
  • Allergic to cyclopentolate eye drops
  • Individuals who, in the judgment of the Investigator, are unable to cooperate and follow instructions during eye examination.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
108 participants (estimated)

Study 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.

    Other: Modified Defocus Incorporated Multiple Segments lens (D1)

  • 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.

    Other: Modified Defocus Incorporated Multiple Segments lens (D2)

Interventions

  • OtherModified Defocus Incorporated Multiple Segments lens (D1)

    D1 is a modified Defocus Incorporated Multiple Segments lens that corrects the distance refraction and provides myopic defocus simultaneously

  • OtherModified Defocus Incorporated Multiple Segments lens (D2)

    D2 is a modified Defocus Incorporated Multiple Segments lens that corrects the distance refraction and provides myopic defocus simultaneously

06

What researchers measure

Primary outcomes

  1. Choroidal thickness changes

    Choroidal thickness will be measured by a swept source optical coherence tomographer. Changes in choroidal thickness from baseline over the first month and every 6 months for 1 year over the study period.

    Time frame: Baseline, every week for 1 month, every 6 months over 1 year

Secondary outcomes

  1. Cycloplegic refraction change in spherical equivalent refraction (SER)

    Cycloplegic SER (in diopter) will be measured using an open field autorefractor. Change in SER with cycloplegia from the baseline every 6 months for 1 year over the study period.

    Time frame: Baseline, 6 and 12 months

  2. Axial length changes

    Axial length (mm) will be measured after cycloplegia using a non-contact optical biometer. Change in axial length from the baseline every 6 months for 1 year over the study period.

    Time frame: Baseline, 6 and 12 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2026 (actual). Primary completion is estimated for Dec 2027, 20 months after the start.

Of 200 non-industry interventional studies with no phase under Myopia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 20 months is below that.

Counting every sponsor, half of 434 studies reached it within 14 months; a quarter within 3 and three quarters within 34.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 17, 2026
First posted
Apr 23, 2026
StartActual
Apr 24, 2026
Primary completionEst.
Dec 31, 2027
CompletionEst.
Feb 29, 2028
Last update
Sep 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07547072
Lead sponsor
The Hong Kong Polytechnic University
Collaborators
HOYA Lens Thailand LTD.
Responsible party
Sponsor
First posted
Apr 23, 2026
Start date
Apr 24, 2026
Primary completion
Dec 31, 2027 (estimated)
Completion
Feb 29, 2028 (estimated)
Last update
Sep 17, 2026

Study contacts

Rachel Ka Man Chun, PhD
Contact
rachel.chun@polyu.edu.hk
852-27664224
Dennis Yan Yin Tse, PhD
Contact
dennis.tse@polyu.edu.hk
852-27666096
Rachel Ka Man Chun, PhD
principal investigator · School of Optometry, The Hong Kong Polytechnic University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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