Myopia
Conditions
Interventions
Group 1:Wearing Intelligent or Digital Lens Design Corneal Reshaping Lenses
Group 2:Wearing Intelligent or Digital Lens Design Corneal Reshaping Lenses
Sponsors
Tianjin Eye Hospital
Eligibility
Sex/Gender
All
Age
8 Years to 13 Years
Inclusion criteria
Inclusion criteria: (1) 8 years old = age = 13 years old, male and female are not limited; (2) Myopia of both eyes within -1.00D~-4.00D (including -1.00D and -4.00D), astigmatism within 1.5D (including 1.5D), and refractive error =1D in both eyes; (3) Best-corrected visual acuity = 1.0 in both eyes; (4) Subjects and their guardians understood the content of the study and voluntarily signed an informed consent form.
Exclusion criteria
Exclusion criteria: (1) One eye meets the inclusion criteria; (2) Those who suffer from systemic diseases resulting in immunocompromise, or those who have an effect on corneal reshaping (e.g., previous diabetes, Down's syndrome, rheumatoid arthritis, psychiatric disorders, etc., or those who have suffered from acute or chronic sinusitis within 1 year, etc.); (3) Those suffering from corneal anomalies, previous corneal surgeries or history of corneal trauma, or corneal hyperalgesia; (4) Those with the following symptoms in the eye: 1. Active corneal infections of bacterial, fungal, or viral origin; 2. Acute and chronic inflammation of the anterior segment of the eye other than the cornea, such as acute conjunctivitis and blepharitis; 3. Any ocular disorder, injury, or structural abnormality that affects the cornea, conjunctiva, or eyelids, e.g., lachrymatorrhoea, glaucoma; 4. Dry eye (Fluorescein Staining Tear Film Breakup Time (FBUT) = 5 s); 5. Corneal staining = grade 2; ? Other pathological ocular congestion or redness. (5) Best-corrected distance visual acuity of less than 1.0 in either eye; (6) Corneal flat curvature (measured by corneal topographer) below 40.00D or above 46.00D; (7) Those with unstable refractive error; (8) Those with irregular corneal astigmatism; (9) Those with dominant strabismus; (10) Abnormal intraocular pressure (normal intraocular pressure ranges from 10 to 21 mmHg, and the difference in intraocular pressure between both eyes should be less than 5 mmHg); (11) Those with corneal endothelial cell density less than 2000 cells/mm2; (12) Those who have worn keratoplasty lenses within the previous 30 days; (13) Those with a history of allergy to contact lenses or contact lens care solutions; (14) Use of medications for dry eye treatment within 1 month prior to screening, as well as those who are using, or plan to use during the study, medications that may affect the fitting of the test product, cause dry eye, affect vision and corneal curvature, or alter normal eye physiology (e.g., immunosuppressants, glucocorticosteroids, intraocular pressure-lowering medications, and therapeutic pupil dilators, etc.); (15) Those who participated in other drug clinical trials within 3 months and other medical device clinical trials within 30 days prior to screening (if the medical device clinical trial participated in is a soft contact lens clinical trial, only those who have participated in a soft contact lens clinical trial within 1 week are excluded); (16) Those who are unable to understand the limitations and reversibility of myopia correction by keratoplasty; (17) Those whose test results suggest other contraindications to fitting or unsuitability for keratoplasty lenses; (18) Those who are unable to have regular eye examinations (or whose relatives are unable to accompany the minor on a regular basis); and (19) Any other conditions that, in the judgement of the investigator, make the subject unsuitable for enrolment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| residuary refractive error;Axial length;visual acuity; | — |
Secondary
| Measure | Time frame |
|---|---|
| corneal topography;wavefront aberration;retinal defocus;comfort and satisfaction survey;objective refraction with cycloplegia; | — |
Countries
China
Contacts
Public ContactLi Lihua
Tianjin Eye Hospital
Outcome results
None listed