soft peripheral contact lens for eye elongation control (space):1-year results of a double-blinded randomized con-trolled trial

Conditions: Soft Contact Lens

Summary: a prospective, randomised, double-blinded clinical trial was conducted including 115 children (55 male and 60 female) aged 8 to 15 years. the newest multifocal contact lenses were assigned to experimental group, and another commercial dual-focus optical designed contact lenses were assigned to control group to be worn for at least 8 hours per day, 7 days a week, for a period of 1 year. all contact lenses were replaced with new lenses every day. measurements obtained using a logmar vision meter, including automated computerised optometry, handheld retinoscopy, high (96%) and low (12%) contrast sensitivity visual acuity values at a distance, and near-visible acuity values were used to evaluate the corneal curvature using a corneal mapper. additionally, the axial length(axl) of the eye was measured, and the tear quality was assessed using a slit lamp, including tear break-up time, tear river height, and observation of blink frequency. furthermore, the eye's anterior surface was examined by slit lamp using the efron grading scale.


Eligibility criteria:
inclusion criteria: * subjects must be between the ages of 8 and 15 (both 8 and 15 years old). * subject's best corrected visual acuity must be at least logmar 0.10 or higher in both eyes. * the subject's eyes must be healthy and normal, and "normal eyes" is defined as having the following characteristics. 1. based on the slit-lamp examination results of the screening clinic, determined that the infection of the conjunctiva, eyelids and accessory organs was less than grade 2 (mild). 2. no structural abnormality of the eyelid, conjunctiva or accessory organ tissue. 3. slit lamp findings must be less than grade 1 (mild) and the cornea must not show: edema, staining, clouding, or vascularization according to the slit lamp findings of the screening clinic. 4. no iritis. 5. there are no other active eye diseases that are not suitable for contact lens wear. * no topical eye drops are currently being used. * the subject and his/her legal representative (if the subject is under 20 years old) are willing to sign the subject's consent form. * legal guardians of subjects under 12 years of age are willing to sign the informed consent form. * meet the following refractive criteria determined by cycloplegic autorefraction at baseline 1. spherical equivalent refractive error: between -0.75 and -6.00 d inclusive 2. astigmatism: ≤-0.75 d 3. anisometropia: \<1.00 d exclusion criteria: * participants with certain eye diseases that may affect their eye health or may be aggravated by the test product. * those who are unable to comply with regular tracking and inspection. * subject is currently participating, or has participated in another drug trial within 4 weeks prior to enrollment in this trial. * subject has undergone any eye surgery or corneal surgery. * subject has used systemic steroids, other systemic medications that may significantly affect vision or recovery, ophthalmic steroids, eye ointments, or pupil dilators (except for examination pupil dilators) within 2 weeks prior to trial entry. * those who are unable to cooperate with regular tracking and inspection. * participants with poor hygiene practices that may compromise safety during the trial or be inconsistent with the participant's best interests.

Keywords: axial length children myopia control soft contact lens clinical trials