Refractive error
Conditions
Interventions
Intervention Group 1:Wearing toric soft contact lenses
Intervention Group 2:Wearing point diffusion and defocus soft lenses
Control group:Wearing defocus soft contact lenses
Sponsors
Eye & ENT Hospital of Fudan University
Eligibility
Sex/Gender
All
Age
7 Years to 11 Years
Inclusion criteria
Inclusion criteria: 1.Participants must be between 7 and 11 years old (under 12 years) at the initial screening; 2.Participants and their parents/legal guardians must: (1).Read the informed consent form;(2)Be fully informed and have the consent form explained ; (3). Indicate understanding of the consent form ; (4). Sign the informed consent form; 3.Understand the nature of this study together with parents/legal guardians and be willing to comply with the requirements of this trial; 4. Agree with parents/legal guardians to follow the trial schedule; 5.Agree to wear the assigned study contact lenses at least 6 days per week, with an average daily wear time of at least 10 hours; if the wearing schedule needs to be interrupted during the trial, notify the trial ophthalmologist and research staff. If the interruption is due to health reasons, the trial ophthalmologist may adjust the wearing time as appropriate 6.Maintain good physical health; 7.Participants must have high-contrast unaided visual acuity of 0.10 logMAR (0.8) or better in both eyes ; 8.Cycloplegic refraction at initial screening (using computerized refraction) must meet the following criteria: (1).Spherical equivalent range from +0.75 D (inclusive) to -6.00 D (exclusive) ;(2).Astigmatism >= -1.00 D ;(3) Anisometropia <= 1.00 D
Exclusion criteria
Exclusion criteria: 1.The study participant is currently participating in another clinical trial or has participated in another clinical trial within 30 days prior to this study; 2. The study participant is currently using or has used any form of myopia control method within 30 days prior to participating in this study, including but not limited to: Any type of bifocal/multifocal glasses,Any type of bifocal/multifocal contact lenses,Any type of orthokeratology lenses ,Atropine 3.Habitual use of systemic or topical medications that may alter normal eye examination results, are known to affect the participant’s eye health, or may adversely or beneficially affect the participant’s ocular health and thereby impact physiological or contact lens performance during the clinical trial; 4. Known allergy to compound tropicamide eye drops; 5. Strabismus measured at a distance of 3 m or near at 40 cm during cover testing; 6. Known ocular or systemic diseases, for example but not limited to: Diabetes, Graves’ disease, Glaucoma, Uveitis, Scleritis,Autoimmune diseases, such as ankylosing spondylitis, multiple sclerosis, systemic lupus erythematosus 7.Any ocular, systemic, or neurological developmental conditions that may affect ocular refractive development, for example but not limited to: Congenital pupil remnants, Vitreous hemorrhage ,Cataract ,Central corneal scar ,Eyelid hemangioma,Marfan syndrome,Down syndrome, Ocular albinism ,Retinopathy of prematurity; 8.Keratoconus or irregular cornea; 9. The investigator ophthalmologist may exclude any individual they deem may not be able to meet the clinical trial requirements or in the best interest of the study participant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Differences in the changes of axial length from baseline to the end of the first year between Intervention Group 1 and the control group, and between Intervention Group 2 and the control group;Differences in the changes from baseline in cycloplegic computerized refraction spherical equivalent between Intervention Group 1 and the control group, and between Intervention Group 2 and the control group during the first year; | — |
Secondary
| Measure | Time frame |
|---|---|
| The difference in changes in sensitivity in the first year between Intervention Group 1 and the control group, and between Intervention Group 2 and the control group;Differences in the changes in choroidal thickness during the first year between Intervention Group 1 and the control group, and between Intervention Group 2 and the control group; | — |
Countries
China
Contacts
Public ContactChen Zhi
Eye & ENT Hospital of Fudan University
Outcome results
None listed