Health TrialsbyHealthPanel

A Randomized Controlled Trial of Autostereoscopic 3D Vision Therapy for Amblyopia

ConditionsAmblyopiaVisual TrainingVisual FunctionsVisual Health
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-12
SponsorBeijing Tongren Hospital

About this trial

The goal of this clinical trial is to learn if an autostereoscopic 3D amblyopia training system works to improve vision in children and adolescents with amblyopia. It will also learn about the safety and tolerability of the 3D training system. The main questions it aims to answer are:

* Does autostereoscopic 3D vision training improve best corrected visual acuity in the amblyopic eye compared to conventional patching therapy? * What side effects or discomfort do participants experience during 3D training versus patching? Researchers will compare the autostereoscopic 3D training system to conventional daily eye patching to see which treatment works better for improving vision in amblyopia.

Participants will:

* Be randomly assigned to either the 3D training group or the patching group * Complete daily home treatment for 6 months - either 20 minutes of 3D vision training or 2 hours of continuous eye patching * Visit the clinic at baseline, 1 month, 3 months, and 6 months for eye exams and vision tests * Have their treatment progress monitored remotely through training data logs or patching diaries

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Unilateral amblyopia (anisometropic, strabismic, or ametropic)

Age: 7 to 12 years

Amblyopic eye BCVA: 0.1 to 0.8 LogMAR

Fellow eye BCVA: ≥ 0.8 LogMAR

Disqualifiers

Deprivation amblyopia (congenital cataract, ptosis, etc.)

Organic ocular disease (glaucoma, retinopathy, optic neuropathy)

Previous ocular surgery or trauma

Severe dry eye or other ocular surface disorders

Trial design

Design model

Parallel

Treatments tested in this trial

  • Autostereoscopic 3D Training

    Device

    Daily 20-minute autostereoscopic 3D amblyopia training session, 5+ days per week for 6 months. Training consists of 15 minutes of monocular perceptual learning with Gabor patches (adaptive difficulty algorithm) and 5 minutes of binocular vergence training. Home-based training with remote data monitoring.

  • Conventional Patching

    Device

    Daily continuous 2-hour occlusion of the non-amblyopic eye using medical adhesive eye patches, 5+ days per week for 6 months. Patients are encouraged to perform near visual activities (reading, writing, puzzles) during patching to enhance amblyopic eye stimulation. Parent-supervised home therapy with daily patching logs.

Treatment groups

34 Participants
are divided into 2 treatment groups
Group A: Autostereoscopic 3D Training GroupExperimental treatment 1 intervention
Group B: Conventional Patching GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Best Corrected Visual Acuity (BCVA)

Time frame
baseline to 6 months

Secondary outcomes

1

Distance Stereoacuity

Time frame
baseline to 6 months
2

Near Stereoacuity

Time frame
Baseline to 6 months
3

Contrast Sensitivity Function

Time frame
Baseline to 6 months
4

Computer Vision Syndrome Questionnaire (CVS-Q) Score

Time frame
Baseline to 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Tongren Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: