Clinical trial NCT06995911: Virtual Far-sight Reading Device for Myopia Intervention Among Pre-myopic Children
Official title: A Randomized Controlled Clinical Trial on the Efficacy and Safety of the Virtual Far-sight Reading Device for Myopia Intervention in Pre-myopic Children
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Myopia
Pre-myopia
Keywords: Myopia
Pre-myopia
Lead sponsor: Shanghai Eye Disease Prevention and Treatment Center
Sponsor class: OTHER
First posted: 2025-05-30
Enrollment: 80
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This randomized controlled crossover trial was conducted in two sequential phases:

Phase I (Day 0-90):

Group A: Performed daily near-work activities (e.g., reading/writing) using the Virtual Far-sight Reading Device with cumulative daily use ≥60 minutes.

Group B: Engaged in routine near-work activities without intervention.

Phase II (Day 90-180):

Group A: Switched to standard near-work practice without device use.

Group B: Initiated Virtual Far-sight Reading Device intervention under identical protocol (≥60 min/day cumulative use).
Primary purpose: PREVENTION

Brief summary: 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

Detailed description: The Virtual Far-sight Reading Device is an innovative ocular protection device integrating advanced far-image optical technology, designed to alleviate asthenopia and prevent myopia progression by simulating a long-distance visual environment. Utilizing a birdbath optical configuration and freeform surface technology, it extends the working distance from 30 cm to over 6 meters, mimicking natural distance viewing to induce ciliary muscle relaxation. The device incorporates a cinematic-grade 2K true-color retinal display combined with a peripheral defocus optical design to generate hyperopic retinal shifts, thereby suppressing myopia development. Additional features include an embedded high-resolution AI camera, full-spectrum LED auxiliary lighting (CCT 5000K, CRI \>90), and compatibility with extensive e-learning resources, making it suitable for diverse scenarios such as online classes, reading, and writing tasks.

This study employs a randomized controlled crossover trial to evaluate the efficacy and safety of the device in pre-myopic children and adolescents. Participants are divided into Groups A and B, with Phase I (Days 0-90) requiring Group A to perform daily near-work activities using the device for ≥60 minutes of cumulative daily use, while Group B follows conventional near-work practices without intervention. During Phase II (Days 91-180), the interventions are reversed between groups. Comprehensive ophthalmic evaluations are conducted at baseline, Day 90, and Day 180 to assess changes in spherical equivalent refraction (SER), axial length (AL), myopia incidence rate, binocular visual function parameters, and ocular morphological metrics, ensuring rigorous analysis of both therapeutic outcomes and safety profiles.

Eligibility criteria: Inclusion Criteria:

* 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

      ⑥ Compliance: Commitment to daily home use of the Far-Image Light Field Desk per protocol, immediate notification to investigators if unable to comply, and completion of scheduled follow-ups.

      ⑦ Informed consent: Signed assent form (minor) and written informed consent from legal guardian.

Exclusion Criteria:

* 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

      ⑤ Medications affecting efficacy evaluation (within 3 months): Anticholinergics (e.g., atropine, pirenzepine); Cholinergics (e.g., pilocarpine)

      ⑥ Participation in other clinical trials within 3 months.

      ⑦ Contraindications/allergies to cycloplegics or study-related medications.

      ⑧ Chronic psychiatric disorders or cognitive impairment.

      ⑨ Other conditions deemed unsuitable by investigators.

Primary outcomes:
measure: Changes in Spherical Equivalent Refraction
timeFrame: 90 and 180 days from baseline
Secondary outcomes:
measure: Changes in Axial Length
timeFrame: 90 and 180 days from baseline
measure: Cumulative Incidence of Myopia
timeFrame: 90 and 180 days from baseline
Other outcomes:
measure: Changes in Accommodative Response
timeFrame: 90 and 180 days from baseline
measure: Changes in Facility of Accommodation
timeFrame: 90 and 180 days from baseline
measure: Changes in Positive/Negative Relative Accommodation
timeFrame: 90 and 180 days from baseline
measure: Changes in Amplitude of Accommodation
timeFrame: 90 and 180 days from baseline
measure: Changes in Lens Thickness
timeFrame: 90 and 180 days from baseline
measure: Changes in Choroidal Thickness
timeFrame: 90 and 180 days from baseline
measure: Changes in Best Corrected Visual Acuity
timeFrame: 90 and 180 days from baseline
measure: Changes in Strabismus
timeFrame: 90 and 180 days from baseline
measure: Changes in Asthenopia Score
timeFrame: 90 and 180 days from baseline
Locations:
city: Shanghai
country: China
facility: Shanghai Eye Disease Prevention and Treatment Center
Study officials:
References: