myopia
Conditions
Interventions
monocular group:Wear single vision frames for one month
Defocus frame lens group :Wear defocus frame lens for one month
keratomileusis (lens) group:Wear keratomileusis for one month
monocular group(Part 3):Wear single vision frames for one year
Defocus frame lens group (Part 3):Wear defocus frame lens for one year
keratomileusis (lens) group(Part 3):Wear keratomileusis for one year
Sponsors
The Affiliated Yongchuan Hospitalof Chongoing Medical University
Eligibility
Sex/Gender
All
Age
4 Years to 18 Years
Inclusion criteria
Inclusion criteria: Part ?: (1) Age 4-18 (inclusive), gender-neutral (2)Myopia in both eyes, equivalent spherical lens (SE) -8.00D to +6.00D (computerized optometry after ciliary muscle paralysis), astigmatism =1.50D in both eyes (3)Refractive error (in equivalent spherical lenses) 1.0 or LOgMAR 1.0 or LOgMAR <0 (5)Obtain written informed consent signed by the legal guardian or both the child and the legal guardian. Part III: Same as Part II.
Exclusion criteria
Exclusion criteria: Part?:Part I: Those who are participating in other clinical trials; those with dominant strabismus (including intermittent strabismus, trismus, or amblyopia) in either eye. (including intermittent strabismus, >15 prism degrees on trinocular examination), current or past history of amblyopia; any disease or syndrome that may cause severe myopia (e.g., Marfan syndrome, Stickler syndrome, retina of prematurity). History of any disease or syndrome that may lead to severe myopia (e.g., Marfan syndrome, Stickler syndrome, retinopathy of prematurity, etc.); abnormalities of the refractive media in any eye (e.g., corneal, lens abnormalities, etc.). Refractive media abnormalities in any eye (e.g., corneal, lens abnormalities, etc.); glaucoma or stenosis of the atrial angle in any eye or a history thereof; current or previous severe corneal injury; and history of severe corneal injury, ocular surgery, or laser treatment; use of myopia-control treatments other than those in this study in the 6 months prior to screening, such as low-concentration albuterol (LCA), or other myopia-control treatments. Use of myopia control treatments other than this study in the 6 months prior to screening, e.g., low-concentration atropine drops, repeated low-intensity red light, etc.; contraindications to contact lens wear; family history of high myopia; inability to fixate the visual field; and history of high myopia; inability to fixate the visual field and obtain a clear choroidal image. Poor compliance and inability to make timely and regular visits to the healthcare provider as required. Other conditions deemed inappropriate for enrollment by the investigator. Part? (1) Contraindications to contact lens wear: active corneal infection, or other acute or chronic inflammation of the anterior segment of the eye, etc. (2) Participating in other clinical trials (3) Current or past history of dominant strabismus (including intermittent strabismus with >15 prism degrees of strabismus on triple prism examination), amblyopia in any eye; history of any disease or syndrome that may lead to severe myopia (e.g., Marfan Syndrome, Stickler Syndrome, Retinopathy of Prematurity, etc.); refractive media abnormality (e.g., corneal, lens anomalies, etc.) in any eye; refractive media abnormality (e.g., corneal, lens anomalies, etc.) in any eye; or any eye with Glaucoma or atrial angle stenosis or past medical history; current or past medical history of severe corneal injury, ocular surgery, or laser treatment; use of myopia control treatments other than those in this study in the 6 months prior to screening, such as low-concentration atropine eye drops, repetitive low-intensity red light, etc.; family history of high myopia; and inability to fixate on a visual target to obtain a clear choroidal image. Poor compliance and inability to visit a healthcare provider in a timely and regular manner as required; other conditions deemed by the investigator to be unsuitable for enrollment. Part III: Same as Part II.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in axial length for one year;Changes in choroidal thickness for one month; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in choroidal thickness for 12 months; | — |
Countries
China
Contacts
Public ContactWu Ziyun
The Affiliated Yongchuan Hospitalof Chongoing Medical University
Outcome results
None listed