Ignite Creation Date:
2024-07-17 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06498206
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-07
Brief Title:
AR Training Versus Patching in Unilateral Amblyopia
Sponsor:
Eye ENT Hospital of Fudan University
Organization:
Eye ENT Hospital of Fudan University
Study Overview
Official Title:
Dichoptic Augmented Reality AR Training Versus Patching for Unilateral Amblyopia in Children and Adults
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
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 dichopticbinocular 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 PM 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 3 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
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 PM 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 3 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None