AR Training Versus Patching in Unilateral Amblyopia

April 8, 2025 updated by: Eye & ENT Hospital of Fudan University

Dichoptic Augmented Reality (AR) Training Versus Patching for Unilateral Amblyopia in Children and Adults

This is a multi-center, randomized controlled trial to compare the effectiveness of AR training with patching for the treatment of unilateral amblyopia.

Specific Aim 1 (Primary): To compare the improvement of visual acuity in the amblyopic eye between AR training and patching for the treatment of unilateral amblyopia.

Specific Aim 2 (Secondary): To compare the improvement of visual functions between AR training and patching for the treatment of unilateral amblyopia.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Poor compliance, limited improvement of visual functions, and regression after recovery of visual acuity have been observed in the management of amblyopia using conventional patching. Recently, dichoptic/binocular digital therapy has been developed, but no widely accepted binocular treatments with superiority available for children and adults with amblyopia (Pineles et al., 2020; Oscar et al., 2023). Here, we designed an innovative binocular therapy using augmented reality (AR) training, based on neural deficits in amblyopia, to achieve better outcomes.

Selective deficits were found in the parvocellular pathway (P pathway) compared to the magnocellular pathway (M pathway) in the monocular processing of visual information in the amblyopic eye (AE) (Wen et al., 2021). In addition to monocular deficits, imbalanced binocular suppression may also play important roles in the visual deficits of amblyopia as suggested by clinical evidence (DeSantis, 2014; Von Noorden, 1996) and psychophysical studies (Baker et al., 2008; Holopigian et al., 1988; Li et al., 2011; Zhou et al., 2013). Based on the neural deficits in unilateral amblyopia, we first apply the push-pull approach (Xu, He & Ooi, 2010; Ooi et al., 2013), which was aimed to reduce sensory eye dominance in previous literatures, into the rebalance of functions of M and P pathways in the AE and the rebalance of binocular interaction, to improve the high spatial detail perception of the AE in daily life under binocular viewing condition, as well as binocular functions.

Using AR technique combined with dichoptic device, we present differentially-processed images to each eye of the patients in real time, allowing them to interact with the surrounding environment during the visual training. Using a Butterworth filter with the cutoff at 2 cycle pre degree, the images captured in real time are divided into information with high and low spatial frequencies (SFs) corresponding to the P and M pathways, respectively. For the AE, original low SF phase of captured images is scrambled into random noise with the refresh rate of the display, while the original information with high SF is retained completely. As a result, the function of the P pathway is pulled while the function of the M pathway is pushed, actively encouraging the interaction with the surrounding environment through high SF information. For the fellow eye (FE), original high SF phase of captured images is scrambled into random noise with increased contrast and reduced temporal frequency, while the contrast of the original high SF information is reduced. As a result, in addition to the push-pull in monocular P&M pathways, the function of the P pathway in the FE is pulled and while the function of the P pathway in the AE is pushed, actively improving the rebalance of binocular inhibition.

The proposed trial will be conducted in 4 different study sites in China. For the AR training group, patients need to perform AR training for 2 hours per day at home. For the patching group, patients need to patch the FE for 2 hours per day at home.

Study Type

Interventional

Enrollment (Estimated)

114

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Eye & ENT Hospital of Fudan University
        • Contact:
          • Rui Liu
        • Contact:
        • Contact:
          • Wen Wen
        • Contact:
          • Chen Zhao
        • Contact:
          • Yulian Zhou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged 5-55 years (including 5 years and 55 years);
  2. Best-corrected visual acuity worse than 20/30 but no worse than 20/200 in the amblyopic eye, interocular difference of 2 or more lines, with the better eye within the normal range;
  3. Patients have applied optical refractive correction for more than 3 months;
  4. Ability attend visits and complete the treatment;
  5. Normal binocular alignment including strabismic amblyopia with orthotropia after surgical correction, or intermittent exotropia within a range of -15 to 0 prism diopters measured by the prism cover test.

Exclusion Criteria:

  1. Organic eye diseases preventing the establishment of good vision (e.g. ptosis, media opacity, nystagmus, paracentral fixation, acute inflammation like keratitis, optic nerve diseases like glaucoma, retinal diseases);
  2. Lesions of the brain preventing the establishment of good vision (e.g. cortical visual impairment);
  3. Implantable electronic device;
  4. A history of ocular surgery (except strabismus surgery) affecting vision (e.g. retinal detachment repair);
  5. A history of ocular trauma affecting vision;
  6. Receiving amblyopia therapy (except wearing glasses) within 2 weeks prior to presentation;
  7. History of epilepsy or mental illness, or cognitive defects;
  8. Currently taking medications or needing to take medications during the study period that may affect vision;
  9. Inability to comply with the treatments or follow-up visits required;
  10. Participation in clinical trials on drugs within 3 months prior to presentation, or clinical trials on other medical devices within 30 days prior to presentation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Patching group
Conventional patching therapy.
Other: Patching
Conventional patching therapy.
Experimental: AR training group
Dichoptic augmented reality training with dual-pathway (parvocellular pathway and magnocellular pathway) and interocular push-pull paradigms developed based on neural deficits in unilateral amblyopia.
Other: AR training
Dichoptic augmented reality training with dual-pathway (parvocellular pathway and magnocellular pathway) and interocular push-pull paradigms developed based on neural deficits in unilateral amblyopia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total effective rate
Time Frame: 13 weeks
The effective rate is defined as the proportion of patients whose best-corrected visual acuity (BCVA) at distance improved ≥0.2 LogMAR after treatment compared to the baseline. BCVA at distance is measured with ETDRS chart.
13 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in stereopsis
Time Frame: 2 weeks, 4 weeks, 9 weeks, 13 weeks
Near and far stereopsis measured with Randot Stereotest pattern.
2 weeks, 4 weeks, 9 weeks, 13 weeks
Change in contrast sensitivity
Time Frame: 2 weeks, 4 weeks, 9 weeks, 13 weeks
Contrast sensitivity in each eye measured with contrast sensitivity testing instrument CSV-1000®.
2 weeks, 4 weeks, 9 weeks, 13 weeks
Change in best-corrected visual acuity
Time Frame: 2 weeks, 4 weeks, 9 weeks, 13 weeks
Best-corrected visual acuity is measured with cycloplegic refraction, using ETDRS chart.
2 weeks, 4 weeks, 9 weeks, 13 weeks
Effective rate
Time Frame: 2 weeks, 4 weeks, 9 weeks
The effective rate is defined as the proportion of patients whose best-corrected visual acuity (BCVA) at distance improved ≥0.2 LogMAR after treatment compared to the baseline. BCVA at distance is measured with ETDRS chart.
2 weeks, 4 weeks, 9 weeks
Change in habitual visual acuity
Time Frame: 2 weeks, 4 weeks, 9 weeks, 13 weeks
Habitual visual acuity is measured under habitual refractive correction at a viewing distance of 4 meters, using ETDRS chart.
2 weeks, 4 weeks, 9 weeks, 13 weeks
Compliance rate
Time Frame: 2 weeks, 4 weeks, 9 weeks, 13 weeks

Compliance rate is measured by daily card in the patching group and by background recording in the AR training group.

Compliance Rate (%) = (Completed Treatment Days / Scheduled Treatment Days) × 100
2 weeks, 4 weeks, 9 weeks, 13 weeks
Safety reports
Time Frame: 2 weeks, 4 weeks, 9 weeks, 13 weeks
Assessment of the types (adverse event, serious adverse event, device deficiency), incidence rate (%), and frequency (number of events) of adverse events and device-related adverse events occurring during the clinical trial.
2 weeks, 4 weeks, 9 weeks, 13 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Normal proportion in the worth-4 dot test
Time Frame: 2 weeks, 4 weeks, 9 weeks, 13 weeks
The proportion of patients in each group with normal results in the worth-4 dot test.
2 weeks, 4 weeks, 9 weeks, 13 weeks
Normal proportion in the Bagolini striated glasses test
Time Frame: 2 weeks, 4 weeks, 9 weeks, 13 weeks
The proportion of patients in each group with normal results in the Bagolini striated glasses test.
2 weeks, 4 weeks, 9 weeks, 13 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eye & ENT Hospital of Fudan University

Collaborators

First Affiliated Hospital of Fujian Medical University
Jiangsu Provincial People's Hospital
Shanghai Tongren Hospital, Shanghai Jiao Tong University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2024

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

July 7, 2024

First Submitted That Met QC Criteria

July 11, 2024

First Posted (Actual)

July 12, 2024

Study Record Updates

Last Update Posted (Actual)

April 10, 2025

Last Update Submitted That Met QC Criteria

April 8, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-ARTA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We concerns about patient privacy issues and it's better to protect the publication potential.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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