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Preliminary Clinical Observation of Far-Infrared Functional Frame Glasses in Slowing Axial Length Growth in Myopic Children: A Prospective Randomized Controlled Pilot Study

Preliminary Clinical Observation of Far-Infrared Functional Frame Glasses in Slowing Axial Length Growth in Myopic Children: A Prospective Randomized Controlled Pilot Study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600128381
Enrollment
Unknown
Registered
2026-07-20
Start date
2026-07-20
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

Interventions

Control group:The control group wears ordinary spectacles with single-vision resin lenses (prescription prepared according to refraction results), and wears the stu
Experimental group:The experimental group wore functional frame glasses with far-infrared properties. The frame material was Kaijingshi, and the lenses were single-vision resin lenses (with diopters p

Sponsors

Eye Hospital, Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1.Age 6 to 12 years at enrollment; gender is not restricted; 2.Computerized refraction after bilateral ciliary muscle paralysis: -0.75D = 5.0; 6.Intraocular pressure in both eyes >= 10 mmHg and <= 21 mmHg; 7.No other organic lesions in either eye that affect visual acuity; 8.The subject and guardian understand the purpose of this trial and have signed the informed consent form; the subject is able to cooperate with treatment and related ophthalmic examinations, and will not take any myopia prevention or control measures other than those specified in the study protocol during the entire study period.

Exclusion criteria

Exclusion criteria: 1.Individuals diagnosed with manifest strabismus; 2.Congenital color vision deficiency (color blindness); 3.Any eye disease or ophthalmic surgery (including strabismus surgery) that may be associated with myopia or affect refractive development, as well as systemic or other conditions such as Marfan syndrome, retinopathy of prematurity, or diabetes; 4.Eye injuries or diseases of the cornea, conjunctiva, or eyelids (including keratoconus and herpetic keratitis), or retinal lesions, which the investigator assesses as likely to affect study results; 5.Use of any myopia control measures other than single-vision lenses within the past 3 months; 6.Having undergone binocular vision training or flip-card training within the past 1 month; 7.Photophobia or inability to open the eyes normally; 8.Any anatomical, skin, or other conditions that may interfere with the wearing of spectacles; 9.Participation in another clinical trial within 3 months prior to enrollment; 10.The subject has acute or chronic diseases (including other currently existing acute or chronic pain) or psychiatric disorders, etc., which may increase the risks associated with study participation or the use of the investigational product, or may affect the interpretation of study results, and which, in the judgment of the investigator or a designated medically qualified person, render the subject unsuitable for enrollment in this study;

Design outcomes

Primary

MeasureTime frame
Change in axial length from baseline;

Secondary

MeasureTime frame
Equivalent spherical power;Choroidal Thickness Measurement;Pathological changes in fundus photography;Visual quality;Best corrected visual acuity;Incidence of adverse events;

Countries

China

Contacts

Public ContactChen Jie

Eye Hospital, Wenzhou Medical University

cjie@sunyopt.edu+86 577 88068817

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026