Amblyopia UnilateralNCT06498206
AR Training Versus Patching in Unilateral Amblyopia
A study testing AR training and Patching in people with Amblyopia Unilateral, run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 55 years
- Conditions the study is for
- Amblyopia Unilateral
- What is being tested?
- AR training and Patching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Aged 5-55 years (including 5 years and 55 years);
- 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;
- Patients have applied optical refractive correction for more than 3 months;
- Ability attend visits and complete the treatment;
- 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.
Who cannot join
- 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);
- Lesions of the brain preventing the establishment of good vision (e.g. cortical visual impairment);
- Implantable electronic device;
- A history of ocular surgery (except strabismus surgery) affecting vision (e.g. retinal detachment repair);
- A history of ocular trauma affecting vision;
- Receiving amblyopia therapy (except wearing glasses) within 2 weeks prior to presentation;
Show all 10Show fewer
- History of epilepsy or mental illness, or cognitive defects;
- Currently taking medications or needing to take medications during the study period that may affect vision;
- Inability to comply with the treatments or follow-up visits required;
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yulian Zhou, MD contact
China1 site, 1 recruiting
- Recruiting
Eye & ENT Hospital of Fudan University
Shanghai
Wen Wen, MD, PhD, 86+(021)34233133, wenweneye@126.com
Wen Wen
About this study
Official title: 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.
Read the 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.
- Conditions
- Amblyopia Unilateral
- Being tested
- AR training, Patching
- Keywords
- Augmented reality training, Dichoptic therapy, Patching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AR trainingOther
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.
PatchingOther
Conventional patching therapy.
| Study group | Role | What they receive |
|---|---|---|
| AR training group | Experimental | 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. Receives: Other: AR training |
| Patching group | Active comparator | Conventional patching therapy. Receives: Other: Patching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total effective rate
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.
Measured: 13 weeks
Secondary outcomes (7)
Change in best-corrected visual acuity
Best-corrected visual acuity is measured with cycloplegic refraction, using ETDRS chart.
Measured: 2 weeks, 4 weeks, 9 weeks, 13 weeks
Effective rate
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.
Measured: 2 weeks, 4 weeks, 9 weeks
Change in habitual visual acuity
Habitual visual acuity is measured under habitual refractive correction at a viewing distance of 4 meters, using ETDRS chart.
Measured: 2 weeks, 4 weeks, 9 weeks, 13 weeks
Change in stereopsis
Near and far stereopsis measured with Randot Stereotest pattern.
Measured: 2 weeks, 4 weeks, 9 weeks, 13 weeks
Change in contrast sensitivity
Contrast sensitivity in each eye measured with contrast sensitivity testing instrument CSV-1000®.
Measured: 2 weeks, 4 weeks, 9 weeks, 13 weeks
Compliance rate
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
Measured: 2 weeks, 4 weeks, 9 weeks, 13 weeks
Safety reports
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.
Measured: 2 weeks, 4 weeks, 9 weeks, 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start31 Aug 2024
- Primary completionAug 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Amblyopia UnilateralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Fujian Medical University, Shanghai Tong Ren Hospital, Jiangsu Provincial People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06498206
- Sponsor's protocol ID
- 2024-ARTA
- Status last verified
- Apr 2025
- First submitted
- 7 Jul 2024
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We concerns about patient privacy issues and it's better to protect the publication potential.
Publications
Pineles SL, Aakalu VK, Hutchinson AK, Galvin JA, Heidary G, Binenbaum G, VanderVeen DK, Lambert SR. Binocular Treatment of Amblyopia: A Report by the American Academy of Ophthalmology. Ophthalmology. 2020 Feb;127(2):261-272. doi: 10.1016/j.ophtha.2019.08.024. Epub 2019 Oct 13.
PubMed 31619356Cruz OA, Repka MX, Hercinovic A, Cotter SA, Lambert SR, Hutchinson AK, Sprunger DT, Morse CL, Wallace DK; American Academy of Ophthalmology Preferred Practice Pattern Pediatric Ophthalmology/Strabismus Panel. Amblyopia Preferred Practice Pattern. Ophthalmology. 2023 Mar;130(3):P136-P178. doi: 10.1016/j.ophtha.2022.11.003. Epub 2022 Dec 14. No abstract available.
PubMed 36526450Wen W, Wang Y, Zhou J, He S, Sun X, Liu H, Zhao C, Zhang P. Loss and enhancement of layer-selective signals in geniculostriate and corticotectal pathways of adult human amblyopia. Cell Rep. 2021 Dec 14;37(11):110117. doi: 10.1016/j.celrep.2021.110117.
PubMed 34910903DeSantis D. Amblyopia. Pediatr Clin North Am. 2014 Jun;61(3):505-18. doi: 10.1016/j.pcl.2014.03.006. Epub 2014 Apr 14.
PubMed 24852148Von Noorden GK. Binocular vision and ocular motility. Theory and Management of Strabismus. 1996.
Baker DH, Meese TS, Hess RF. Contrast masking in strabismic amblyopia: attenuation, noise, interocular suppression and binocular summation. Vision Res. 2008 Jul;48(15):1625-40. doi: 10.1016/j.visres.2008.04.017. Epub 2008 Jun 10.
PubMed 18547600Holopigian K, Blake R, Greenwald MJ. Clinical suppression and amblyopia. Invest Ophthalmol Vis Sci. 1988 Mar;29(3):444-51.
PubMed 3343099Li J, Thompson B, Lam CS, Deng D, Chan LY, Maehara G, Woo GC, Yu M, Hess RF. The role of suppression in amblyopia. Invest Ophthalmol Vis Sci. 2011 Jun 13;52(7):4169-76. doi: 10.1167/iovs.11-7233.
PubMed 21447685Zhou J, Huang PC, Hess RF. Interocular suppression in amblyopia for global orientation processing. J Vis. 2013 Apr 22;13(5):19. doi: 10.1167/13.5.19.
PubMed 23608341Xu JP, He ZJ, Ooi TL. Effectively reducing sensory eye dominance with a push-pull perceptual learning protocol. Curr Biol. 2010 Oct 26;20(20):1864-8. doi: 10.1016/j.cub.2010.09.043. Epub 2010 Oct 14.
PubMed 20951044Ooi TL, Su YR, Natale DM, He ZJ. A push-pull treatment for strengthening the 'lazy eye' in amblyopia. Curr Biol. 2013 Apr 22;23(8):R309-10. doi: 10.1016/j.cub.2013.03.004.
PubMed 23618663Zhou Y, Guo S, Ling L, Gao Y, Duan X, Liu Y, Liu R, Liu H, Wang H, Lin J, Zhao C, Zhang P, Wen W. Efficacy and safety of augmented-reality pathway-specific binocular training in patients with unilateral amblyopia (ARPSBT): study protocol for a multicenter randomized controlled trial. Trials. 2025 Jul 1;26(1):232. doi: 10.1186/s13063-025-08927-2.
PubMed 40598549
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dichoptic Augmented Reality (AR) Training Versus Patching for Unilateral Amblyopia in Children and Adults
- ClinicalTrials.gov ID
- NCT06498206
- Acronym / sponsor ID
- 2024-ARTA
- Conditions
- Amblyopia Unilateral
- Keywords
- Augmented reality training, Dichoptic therapy, Patching
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Fujian Medical University, Shanghai Tong Ren Hospital, Jiangsu Provincial People's Hospital
- Study start
- 31 Aug 2024 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 12 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AR training group | Experimental | Other: AR trainingDichoptic augmented reality training with dual-pathway (parvocellular pathway and magnocellular pathway) and interocular push-pull paradigms developed based on neural deficits in unilateral amblyopia. |
| Patching group | Active comparator | Other: PatchingConventional patching therapy. |
Who may qualify
- Ages
- 5 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Aged 5-55 years (including 5 years and 55 years);
- 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;
- Patients have applied optical refractive correction for more than 3 months;
- Ability attend visits and complete the treatment;
- 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.
Key exclusion criteria (10 listed)
- 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);
- Lesions of the brain preventing the establishment of good vision (e.g. cortical visual impairment);
- Implantable electronic device;
- A history of ocular surgery (except strabismus surgery) affecting vision (e.g. retinal detachment repair);
- A history of ocular trauma affecting vision;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AR trainingDichoptic 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 group |
| PatchingConventional patching therapy. | Other | Patching group |
Primary outcome
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.
7 secondary outcomes
Change in best-corrected visual acuity
Time frame: 2 weeks, 4 weeks, 9 weeks, 13 weeks
Effective rate
Time frame: 2 weeks, 4 weeks, 9 weeks
Change in habitual visual acuity
Time frame: 2 weeks, 4 weeks, 9 weeks, 13 weeks
Change in stereopsis
Time frame: 2 weeks, 4 weeks, 9 weeks, 13 weeks
Change in contrast sensitivity
Time frame: 2 weeks, 4 weeks, 9 weeks, 13 weeks
Compliance rate
Time frame: 2 weeks, 4 weeks, 9 weeks, 13 weeks
Safety reports
Time frame: 2 weeks, 4 weeks, 9 weeks, 13 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Background: PubMed 31619356Pineles SL, Aakalu VK, Hutchinson AK, Galvin JA, Heidary G, Binenbaum G, VanderVeen DK, Lambert SR. Binocular Treatment of Amblyopia: A Report by the American Academy of Ophthalmology. Ophthalmology. 2020 Feb;127(2):261-272. doi: 10.1016/j.ophtha.2019.08.024. Epub 2019 Oct 13.
- Background: PubMed 36526450Cruz OA, Repka MX, Hercinovic A, Cotter SA, Lambert SR, Hutchinson AK, Sprunger DT, Morse CL, Wallace DK; American Academy of Ophthalmology Preferred Practice Pattern Pediatric Ophthalmology/Strabismus Panel. Amblyopia Preferred Practice Pattern. Ophthalmology. 2023 Mar;130(3):P136-P178. doi: 10.1016/j.ophtha.2022.11.003. Epub 2022 Dec 14. No abstract available.
- Background: PubMed 34910903Wen W, Wang Y, Zhou J, He S, Sun X, Liu H, Zhao C, Zhang P. Loss and enhancement of layer-selective signals in geniculostriate and corticotectal pathways of adult human amblyopia. Cell Rep. 2021 Dec 14;37(11):110117. doi: 10.1016/j.celrep.2021.110117.
- Background: PubMed 24852148DeSantis D. Amblyopia. Pediatr Clin North Am. 2014 Jun;61(3):505-18. doi: 10.1016/j.pcl.2014.03.006. Epub 2014 Apr 14.
- BackgroundVon Noorden GK. Binocular vision and ocular motility. Theory and Management of Strabismus. 1996.
- Background: PubMed 18547600Baker DH, Meese TS, Hess RF. Contrast masking in strabismic amblyopia: attenuation, noise, interocular suppression and binocular summation. Vision Res. 2008 Jul;48(15):1625-40. doi: 10.1016/j.visres.2008.04.017. Epub 2008 Jun 10.
- Background: PubMed 3343099Holopigian K, Blake R, Greenwald MJ. Clinical suppression and amblyopia. Invest Ophthalmol Vis Sci. 1988 Mar;29(3):444-51.
- Background: PubMed 21447685Li J, Thompson B, Lam CS, Deng D, Chan LY, Maehara G, Woo GC, Yu M, Hess RF. The role of suppression in amblyopia. Invest Ophthalmol Vis Sci. 2011 Jun 13;52(7):4169-76. doi: 10.1167/iovs.11-7233.
- Background: PubMed 23608341Zhou J, Huang PC, Hess RF. Interocular suppression in amblyopia for global orientation processing. J Vis. 2013 Apr 22;13(5):19. doi: 10.1167/13.5.19.
- Background: PubMed 20951044Xu JP, He ZJ, Ooi TL. Effectively reducing sensory eye dominance with a push-pull perceptual learning protocol. Curr Biol. 2010 Oct 26;20(20):1864-8. doi: 10.1016/j.cub.2010.09.043. Epub 2010 Oct 14.
- Background: PubMed 23618663Ooi TL, Su YR, Natale DM, He ZJ. A push-pull treatment for strengthening the 'lazy eye' in amblyopia. Curr Biol. 2013 Apr 22;23(8):R309-10. doi: 10.1016/j.cub.2013.03.004.
- Derived from this study: PubMed 40598549Zhou Y, Guo S, Ling L, Gao Y, Duan X, Liu Y, Liu R, Liu H, Wang H, Lin J, Zhao C, Zhang P, Wen W. Efficacy and safety of augmented-reality pathway-specific binocular training in patients with unilateral amblyopia (ARPSBT): study protocol for a multicenter randomized controlled trial. Trials. 2025 Jul 1;26(1):232. doi: 10.1186/s13063-025-08927-2.
- Individual participant dataSharing planned: No. We concerns about patient privacy issues and it's better to protect the publication potential.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yulian Zhou, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AR training and Patching in people with Amblyopia Unilateral, run by Eye & ENT Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wen Wen, MD, PhD (86+(021)34233133, wenweneye@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total effective rate (time frame: 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06498206, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.