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NCT Number: NCT07547072

Choroidal Response to the Modified Defocus Incorporated Multiple Segments Spectacle Lenses

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.

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Key information

Age range

6 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

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

Primary outcomes

  1. Choroidal thickness changes

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

    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.

Secondary outcomes

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

    Time frame: Baseline, 6 and 12 months

    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.

  2. Axial length changes

    Time frame: Baseline, 6 and 12 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dennis Yan Yin Tse, PhD

CONTACT

[email protected]

852-27666096

Rachel Ka Man Chun, PhD

CONTACT

[email protected]

852-27664224

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Collaborators

  • HOYA Lens Thailand LTD.

Registry information

Official study title

Choroidal Responses to the Modified Defocus Incorporated Multiple Segments (DIMS) Spectacle Lenses

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 23, 2026
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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