Choroidal Response to the Modified Defocus Incorporated Multiple Segments Spectacle Lenses

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

Study Overview

• Status: Not yet recruiting
• Conditions: Myopia
• Intervention / Treatment: Other: Modified Defocus Incorporated Multiple Segments lens (D1); Other: Modified Defocus Incorporated Multiple Segments lens (D2)

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.

• Study Type: Interventional
• Enrollment (Estimated): 108
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dennis Yan Yin Tse, PhD; Phone Number: 852-27666096; Email: dennis.tse@polyu.edu.hk
• Study Contact Backup: Name: Rachel Ka Man Chun, PhD; Phone Number: 852-27664224; Email: rachel.chun@polyu.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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); D1 is a modified Defocus Incorporated Multiple Segments lens that corrects the distance refraction and provides myopic defocus simultaneously
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); D2 is a modified Defocus Incorporated Multiple Segments lens that corrects the distance refraction and provides myopic defocus simultaneously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, every week for 1 month, every 6 months over 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 6 and 12 months
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.	Baseline, 6 and 12 months

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Collaborators: HOYA Lens Thailand LTD.
• Investigators: Principal Investigator: Rachel Ka Man Chun, PhD, School of Optometry, The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Estimated): April 25, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): February 29, 2028

Study Registration Dates

• First Submitted: April 17, 2026
• First Submitted That Met QC Criteria: April 17, 2026
• First Posted (Actual): April 23, 2026

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Myopia; Choroidal thickness
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: H-ZGU1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No