Choroidal Response to the Modified Defocus Incorporated Multiple Segments Spectacle Lenses

NCT07547072 | Not Yet Recruiting DMC

• 1 other identifier: H-ZGU1
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Myopia

Keywords

Myopia; Choroidal thickness

Outcome Measures

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.

  Baseline, every week for 1 month, every 6 months over 1 year

Secondary Outcomes (2)

• Cycloplegic refraction change in spherical equivalent refraction (SER)

  Baseline, 6 and 12 months

• Axial length changes

  Baseline, 6 and 12 months

Study Arms (3)

Single vision lens group

NO INTERVENTION

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.

D1 lens group

EXPERIMENTAL

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)

D2 lens group

EXPERIMENTAL

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

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

D1 lens group

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

D2 lens group

Eligibility Criteria

• Age: 6 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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):
• D (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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• HOYA Lens Thailand LTD.: collaborator

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Rachel Ka Man Chun, PhD

  School of Optometry, The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Ka Man Chun, PhD

CONTACT

852-27664224; rachel.chun@polyu.edu.hk

Dennis Yan Yin Tse, PhD

CONTACT

852-27666096; dennis.tse@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Both participants and their guardians will be masked from the grouping. The outcomes assessors will be also masked from the grouping.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: April 23, 2026
• Study Start: April 25, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): February 29, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share