myopia
Conditions
Interventions
Orthokeratology lenses (OK lenses):none
Orthokeratology lenses +low-dose atropine eye drops:none
Soft peripheral defocus contact lenses (MiSight?):none
Single-vision glasses (control group):none
Peripheral defocus glasses + placebo eye drops:none
Sponsors
Changsha Aier Eye Hospital
Eligibility
Sex/Gender
All
Age
8 Years to 14 Years
Inclusion criteria
Inclusion criteria: 1. Spherical equivalent (SE) ranging from -0.75 D to -6.00 D (myopia, inclusive of both limits). 2. Exclusion of active ocular inflammation (e.g., conjunctivitis, keratitis). Exclusion of severe meibomian gland dysfunction (gland dropout rate >50% or severe glandular morphological abnormalities). Exclusion of severe dry eye (non-invasive tear film break-up time [NIBUT] <5 seconds and tear meniscus height [TMH] <0.3 mm, or significant corneal staining). 3. Ability to cooperate during ocular surface examinations (e.g., Keratograph 5M), wavefront aberration measurements, and questionnaire assessments (children aged =10 years can complete certain scales independently; those <10 years require guardian assistance). 4. Signed informed consent from both the child’s legal guardian and the child (if aged =10 years), indicating voluntary participation in the study.
Exclusion criteria
Exclusion criteria: 1. Presence of severe dry eye, advanced meibomian gland dysfunction (MGD), chronic conjunctivitis, or other serious ocular surface disorders. 2. Systemic or topical use of medications that may affect ocular surface health within the past 3 months, such as glucocorticoids, immunosuppressants, or anticholinergics. 3. Diagnosed systemic conditions known to affect tear production or quality, including Sjögren’s syndrome, diabetes mellitus, or rheumatoid arthritis. 4. Previous ocular surgery or trauma that may alter corneal morphology or tear film stability (e.g., corneal cross-linking, keratoplasty, eyelid surgery, or significant corneal scarring);nability to attend scheduled follow-up visits, unreliable communication, or failure to cooperate with study procedures (e.g., refusal to wear study devices or complete assessments). 5. Any condition or circumstance deemed by the investigator to pose a safety risk or interfere with study outcomes (e.g., allergy to contact lens materials, uncontrolled systemic hypertension).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dry Eye Questionnaire-5 (DEQ-5) score;Tear meniscus height (TMH, mm);Meibomian gland morphology score;Non-invasive tear film break-up time;Objective Optical Metrics(Higher-order aberration (HOA) parameters,Subjective Visual Quality);Conjunctival hyperemia grading; | — |
Secondary
| Measure | Time frame |
|---|---|
| Ocular biometric parameters; | — |
Countries
China
Contacts
Public ContactYuanfang Yang
Changsha Aier Eye Hospital
Outcome results
None listed