General refractive error
Conditions
Interventions
Experimental group:Wear conventional myopic spectacles + medical vision training instrument
Control group:Wear conventional myopic spectacles
Sponsors
Eye & ENT hospital of Fudan University
Eligibility
Sex/Gender
All
Age
6 Years to 16 Years
Inclusion criteria
Inclusion criteria: 1.Aged >= 6 years to = 1.0 in both eyes (5.0 in 5-point recording method); 5.Diagnosis of non-presbyopic accommodation disorder;The categories and criteria for inclusion of accommodation abnormalities were as follows (all of the following/multiple categories were met): First, insufficient accommodation: (1) decreased accommodation amplitude, more than 2 D lower than the age-related minimum accommodation amplitude; (2) accommodation lag: BCC results greater than + 0.75 D; (3) decreased flexibility of monocular accommodation, difficulty in passing the - 2.00 D lens; and (4) decreased positive relative accommodation (PRA). Second, excessive accommodation: (1) amplitude of accommodation: normal; (2) preconditioning: BCC results less than + 0.25 D; (3) decreased monocular accommodation sensitivity, + 2.00 D lens passage difficulty; (4) decreased negative relative accommodation (NRA). Third, poor accommodation flexibility: (1) normal accommodation amplitude; (2) normal accommodation response; (3) decreased monocular accommodation sensitivity and difficulty in passing +/- 2.00 D lenses; and (4) decreased or normal positive and negative relative accommodation (PRA, NRA). Fourth, the accommodation could not be sustained: (1) the accommodation amplitude was normal; (2) the accommodation lag: the BCC result was greater than + 0.75 D; (3) the monocular accommodation sensitivity decreased, and it was difficult for the -2.00 D lens to pass through; and (4) the positive relative accommodation (PRA) decreased. 6.Voluntarily participate in this clinical trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Strabismus, form deprivation and congenital amblyopia, intraocular pressure 21 mmHg, high myopia secondary to fundus lesions; 2.Keratitis, conjunctivitis, hordeolum and other eye diseases in the onset period (or treatment period); 3.Pathological eye diseases, including but not limited to diabetic retinopathy, hypertensive fundus diseases, glaucoma eye diseases, cataract surgery, nystagmus and other pathological problems; 4.Organic eye diseases, including but not limited to keratoconus, congenital iris coloboma, lens dislocation, retinitis pigmentosa, optic atrophy, paracentral fixation, strabismus and other organic problems; 5.Previous history of eye surgery and trauma; 6.Products or methods that have been used or are using myopia prevention and control and may interfere with the adjustment function, such as functional spectacles, peripheral spectacles, multifocal soft or rigid contact lenses, orthokeratology lenses (commonly known as"OK lenses"), nursing instrument, etc., as well as other eyedrops with eye adjustment function, such as low concentration atropine eye drops, racemic anisodamine eye drops, etc., but do not cover the mydriatic drugs used in refractive examination; 7.Only one eye meets the inclusion criteria; 8.Patients not wearing conventional myopic spectacles; 9.Suffering from systemic diseases affecting eye health (such as Tang's syndrome, rheumatoid arthritis, multiple sclerosis, etc.); 10.Participated in any myopia control clinical research trial within three months; 11.Mental retardation or mental illness; 12.Patients who cannot be regularly followed up for eye examination; 13.Other conditions that the investigator considers not eligible for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in axial length after 12 months of training in both groups (mm); | — |
Secondary
| Measure | Time frame |
|---|---|
| Compare the change of uncorrected visual acuity between the two groups after 12 months of training;Compare changes in refraction in both groups after 12 months of training;Compare the change of intraocular pressure between the two groups after 12 months of training;Compare the change of best corrected visual acuity between the two groups after 12 months of training;Compare the change of accommodation amplitude between the two groups after 12 months of training;Compare the change of accommodation sensitivity between the two groups after 12 months of training;Compare changes in NRA/PRA between the two groups after 12 months of training;Compare the change of accommodation response between the two groups after 12 months of training;Compare change in AC/A between the two groups after 12 months of training;Adverse Events;Serious Adverse Events;Device-related adverse events;Type of Device Deficiency;Device Deficiency Rate;Frequency of occurrence of device defects; | — |
Countries
China
Contacts
Public ContactHuang Jinhai
Eye & ENT hospital of Fudan University
Outcome results
None listed