Virtual Far-sight Reading Device for Myopia Intervention Among Pre-myopic Children
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorShanghai Eye Disease Prevention and Treatment Center
About this trial
This clinical trial wants to find out if the Virtual Far-sight Reading Device can help prevent or slow down myopia progression in children and teenagers with pre-myopia. We also want to know what makes this treatment work better for some participants and check for any eye or body-related side effects over time.
Main questions:
Can using the Virtual Far-sight Reading Device reduce the risk of myopia? Is the device safe to use every day for up to 6 months?
What we'll do:
Researchers will compare two groups of children:
Group A: Uses the device for reading/writing (at least 1 hour daily) Group B: Does regular reading/writing without the device After 90 days, the groups will switch to see if the results stay the same.
Participants will:
* Have free eye checkups 3 times over 6 months * Use the device during homework time (if in the desk group) * Report any eye discomfort or problems
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: 6-12 years (inclusive), gender unrestricted.
Worse eye cycloplegic spherical equivalent refraction (SER): -0.5 D < SER ≤ +0.75 D; Cylinder ≤ -1.5 D in both eyes; Interocular anisometropia ≤ 1.5 D ③ Visual acuity: Best-corrected visual acuity (BCVA) ≤ 0.1 logMAR in both eyes. ④ Family history: At least one parent with myopia.
Intraocular pressure (IOP): 10-21 mmHg in both eyes; Interocular IOP difference ≤ 5 mmHg
Disqualifiers
Ocular comorbidities affecting vision/refractive development: Marfan syndrome; Lens pathologies (e.g., cataracts); Glaucoma; retinal detachment; retinopathy of prematurity
Systemic diseases: Immune/CNS disorders; Down syndrome; Severe cardiopulmonary/hepatic/renal dysfunction; Uncontrolled asthma
Ocular abnormalities: Manifest strabismus; Binocular vision dysfunction; Pathological ocular changes or active ocular inflammation ④ Recent myopia interventions (within 3 months prior to screening): Orthokeratology; multifocal contact lenses; Functional spectacles, red-light therapy
Trial design
Design model
Crossover
Treatments tested in this trial
Virtual Far-sight Reading Device
DeviceThe Virtual Far-sight Reading Device utilizes a birdbath optical configuration and freeform surface technology to extend the working distance from 30 cm to over 6 meters, thereby simulating distance viewing conditions and maintaining ciliary muscle relaxation. Study participants were required to engage in reading and writing tasks using the device for a cumulative daily duration of at least 1 hour.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Nearwork with the Virtual Far-sight Reading DeviceExperimental treatment 1 intervention
Group B: Nearwork without the Virtual Far-sight Reading DeviceNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Changes in Spherical Equivalent Refraction
Time frame
90 and 180 days from baselineSecondary outcomes
1
Changes in Axial Length
Time frame
90 and 180 days from baseline2
Cumulative Incidence of Myopia
Time frame
90 and 180 days from baselineOther outcomes
1
Changes in Accommodative Response
Time frame
90 and 180 days from baseline2
Changes in Facility of Accommodation
Time frame
90 and 180 days from baseline3
Changes in Positive/Negative Relative Accommodation
Time frame
90 and 180 days from baseline4
Changes in Amplitude of Accommodation
Time frame
90 and 180 days from baselineSponsors and contacts
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Source ClinicalTrials.gov