An interventional study of AR training and Patching in Amblyopia Unilateral and Amblyopia Functional, sponsored by Eye & ENT Hospital of Fudan University. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-11-26.
Sponsored by Eye & ENT Hospital of Fudan University · Not applicable, Interventional, and Treatment
This is a single-center, non-randomized controlled trial to compare the effectiveness of binocular AR training with patching for the treatment of adults with 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 adults with unilateral amblyopia.
Specific Aim 2 (Secondary): To compare the changes of visual functions and pathway selective neural activity in the early visual and cortex subcortical nuclei including the lateral geniculate nucleus between AR training and patching for the treatment of adults with unilateral amblyopia.
Patching the fellow eye (FE) is typically the first line of amblyopia therapy. Patching treatment has been thought to be effective only when started before the age of eight and might bring limited benifits for adults who have decreased visual cortex plasticity (Bhola et al., 2006). However, recent animal and human studies have demonstrated that visual cortex plasticity and visual functions can be enhanced later in life (Kind et al., 2002; Pineles et al., 2020), paving the way for new strategies for amblyopia treatment.
Dichoptic/binocular digital therapy has been developed with hope to improve visual functions in amblyopia post the critical period. However, no widely accepted binocular treatments with superiority to patching is available in adults with unilateral 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, in order 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, images are processed differently and dichopticaly presented to each eye of the patients in real time, same in the content but different in contrast, spatial frequency, temporal frequency, and signal-to-noise ratio, allowing them to interact with the surrounding environment in real time during the visual training. We aim to achieve push-pull in monocular M-P pathways in the AE and interocular P-P pathways in the FE and the AE, in order to selectively improve the function of the P pathway in the AE under binocular viewing condition.
The proposed trial will be conducted in one 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.
183 studies on the registry are indexed under Amblyopia; 43 are open to participants now.
This study's enrollment of 48 is below the median of 60 across 133 interventional studies indexed under Amblyopia.
Browse Amblyopia studies →Eye & ENT Hospital of Fudan University is the lead sponsor of 121 studies on the registry; 67 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dichoptic augmented reality training with dual-pathway (parvocellular pathway and magnocellular pathway) and interocular push-pull paradigms developed based on neural deficits in adults with unilateral amblyopia.
Device: AR training
Conventional patching therapy.
Device: Patching
Dichoptic augmented reality training with dual-pathway (parvocellular pathway and magnocellular pathway) and interocular push-pull paradigms developed based on neural deficits in adults with unilateral amblyopia
Conventional patching therapy.
Change in visual acuity at far
Best-corrected visual acuity in the amblyopic eye measured at the distance of 2.5 meters using standardized logMAR visual charts.
Time frame: 1 week, 1month, 3month, 6month
Change in visual acuity at near
Best-corrected visual acuity in the amblyopic eye measured at the distance of 2.2 meters using the Freiburg Visual Acuity test.
Time frame: 1 week, 1month, 3month, 6month
Change in visual acuity with single tumbling E
Best-corrected uncrowded and crowded visual acuity in the amblyopic eye measured at the distance of 30 centimeters.
Time frame: 1 week, 1month, 3month, 6month
Change in contrast sensitivity
Contrast sensitivity in each eye measured with forced-choice test under binocular viewing.
Time frame: 1 week, 1month, 3month, 6month
Change in faxation stability
Fixation stability in each eye measured with EyeLink 1000.
Time frame: 1 week, 1month, 3month, 6month
Change in binocular phase combination
Binocular integration measured with phase combination test .
Time frame: 1 week, 1month, 3month, 6month
Change in binocular rivalry ratio
Binocular rivalry ratio measured with binocular rivalty test
Time frame: 1 week, 1month, 3month, 6month
Change in stereopsis
Near stereopsis measured with Titmus Fly Stereotest pattern.
Time frame: 1 week, 1month, 3month, 6month
Change in neural activity corresponding to visual inputs in SSVEP
Pathway-selective neural activity in the early visual cortex revealed by SSVEP.
Time frame: 1 week, 1month, 3month, 6month
Change in neural activity corresponding to visual inputs in fMRI
Pathway-selective neural activity in the early visual cortex and subcortical nuclei including lateral geniculate nucleus revealed by fMRI.
Time frame: 1 week, 1month, 3month, 6month
Plan to share: No — We concerns about patient privacy issues and it's better to protect the publication potential.
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Eye & ENT Hospital of Fudan University