Choroidal Response to the Modified Defocus Incorporated Multiple Segments Spectacle Lenses (NCT07547072) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Choroidal Response to the Modified Defocus Incorporated Multiple Segments Spectacle Lenses
108 participantsStarted 2026-04-25
Plain-language 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.
Who can participate
Age range6 Years – 13 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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/supplement…
What they're measuring
1
Choroidal thickness changes
Timeframe: Baseline, every week for 1 month, every 6 months over 1 year