Amblyopia UnilateralNCT06704737
AR Training in Adults With Unilateral Amblyopia
A study testing AR training and Patching in people with Amblyopia Unilateral and Amblyopia Functional, run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Amblyopia Unilateral, Amblyopia Functional
- What is being tested?
- AR training and Patching
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 25 Feb 2023to 20 Dec 2024
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18-50 years (including 18 years and 50 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 with deprivation amblyopia should have relieved the deprivation factors such as opacification of the ocular media (e.g. cataract, nonclearing vitreous opacity, corneal opacities) or other occlusion of the visual axis (e.g. blepharoptosis).
- Normal binocular alignment including strabismic amblyopia with orthotropia after optical refractive correction or surgical correction, or intermittent exotropia within a range of -15 to 0 prism diopters measured by the prism cover test.
- Patients should have been applyng optical refractive correction for more than 3 months before enrollment.
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);
- 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 refractive correction glasses) within 2 weeks before enrollment;
- 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;
- Contraindications to magnetic resonance imaging such as implantable electronic device, metal implants (e.g. metal dentures, craniofacial titanium plates), claustrophobia and pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dichoptic Augmented Reality (AR) Training Versus Patching in Adults With Unilateral Amblyopia
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.
Read the detailed description
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.
- Conditions
- Amblyopia Unilateral, Amblyopia Functional
- Being tested
- AR training, Patching
- Keywords
- Adult, Augmented reality training, Patching, Neural deficit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AR trainingDevice
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
PatchingDevice
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 adults with unilateral amblyopia. Receives: Device: AR training |
| Patching group | Active comparator | Conventional patching therapy. Receives: Device: Patching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week, 1month, 3month, 6month
Secondary outcomes (9)
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.
Measured: 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.
Measured: 1 week, 1month, 3month, 6month
Change in contrast sensitivity
Contrast sensitivity in each eye measured with forced-choice test under binocular viewing.
Measured: 1 week, 1month, 3month, 6month
Change in faxation stability
Fixation stability in each eye measured with EyeLink 1000.
Measured: 1 week, 1month, 3month, 6month
Change in binocular phase combination
Binocular integration measured with phase combination test .
Measured: 1 week, 1month, 3month, 6month
Change in binocular rivalry ratio
Binocular rivalry ratio measured with binocular rivalty test
Measured: 1 week, 1month, 3month, 6month
Change in stereopsis
Near stereopsis measured with Titmus Fly Stereotest pattern.
Measured: 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.
Measured: 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.
Measured: 1 week, 1month, 3month, 6month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start25 Feb 2023
- Primary completion20 Dec 2024 (estimated)
- Study completion20 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Amblyopia UnilateralStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wen Wen, MD, PhD, Study chair, Eye & ENT Hospital of Fudan University, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06704737
- Sponsor's protocol ID
- EENTAR20230225
- Status last verified
- Nov 2024
- First submitted
- 22 Nov 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- 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
Ooi 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 23618663Xu 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 20951044Zhou 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 23608341Li 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 21447685Holopigian K, Blake R, Greenwald MJ. Clinical suppression and amblyopia. Invest Ophthalmol Vis Sci. 1988 Mar;29(3):444-51.
PubMed 3343099Baker 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 18547600Von Noorden GK. Binocular vision and ocular motility. Theory and Management of Strabismus. 1996.
DeSantis 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 24852148Wen 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 34910903Cruz 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 36526450Pineles 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 31619356Kind PC, Mitchell DE, Ahmed B, Blakemore C, Bonhoeffer T, Sengpiel F. Correlated binocular activity guides recovery from monocular deprivation. Nature. 2002 Mar 28;416(6879):430-3. doi: 10.1038/416430a.
PubMed 11919632Bhola R, Keech RV, Kutschke P, Pfeifer W, Scott WE. Recurrence of amblyopia after occlusion therapy. Ophthalmology. 2006 Nov;113(11):2097-100. doi: 10.1016/j.ophtha.2006.04.034.
PubMed 17074568
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dichoptic Augmented Reality (AR) Training Versus Patching in Adults With Unilateral Amblyopia
- ClinicalTrials.gov ID
- NCT06704737
- Acronym / sponsor ID
- EENTAR20230225
- Conditions
- Amblyopia Unilateral, Amblyopia Functional
- Keywords
- Adult, Augmented reality training, Patching, Neural deficit
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 25 Feb 2023 (actual)
- Primary completion
- 20 Dec 2024 (estimated)
- Study completion
- 20 Dec 2024 (estimated)
- First posted
- 26 Nov 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 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AR training group | Experimental | Device: AR trainingDichoptic 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. |
| Patching group | Active comparator | Device: PatchingConventional patching therapy. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged 18-50 years (including 18 years and 50 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 with deprivation amblyopia should have relieved the deprivation factors such as opacification of the ocular media (e.g. cataract, nonclearing vitreous opacity, corneal opacities) or other occlusion of the visual axis (e.g. blepharoptosis).
- Normal binocular alignment including strabismic amblyopia with orthotropia after optical refractive correction or surgical correction, or intermittent exotropia within a range of -15 to 0 prism diopters measured by the prism cover test.
- Patients should have been applyng optical refractive correction for more than 3 months before enrollment.
Key exclusion criteria (8 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);
- 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 refractive correction glasses) within 2 weeks before enrollment;
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 adults with unilateral amblyopia | Device | AR training group |
| PatchingConventional patching therapy. | Device | Patching group |
Primary outcome
Change in visual acuity at far
Time frame: 1 week, 1month, 3month, 6month
Best-corrected visual acuity in the amblyopic eye measured at the distance of 2.5 meters using standardized logMAR visual charts.
9 secondary outcomes
Change in visual acuity at near
Time frame: 1 week, 1month, 3month, 6month
Change in visual acuity with single tumbling E
Time frame: 1 week, 1month, 3month, 6month
Change in contrast sensitivity
Time frame: 1 week, 1month, 3month, 6month
Change in faxation stability
Time frame: 1 week, 1month, 3month, 6month
Change in binocular phase combination
Time frame: 1 week, 1month, 3month, 6month
Change in binocular rivalry ratio
Time frame: 1 week, 1month, 3month, 6month
Change in stereopsis
Time frame: 1 week, 1month, 3month, 6month
Change in neural activity corresponding to visual inputs in SSVEP
Time frame: 1 week, 1month, 3month, 6month
Change in neural activity corresponding to visual inputs in fMRI
Time frame: 1 week, 1month, 3month, 6month
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 26 Nov 2024.
- Results publication: 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.
- Results publication: 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.
- Results publication: 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.
- Results publication: 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.
- Results publication: PubMed 3343099Holopigian K, Blake R, Greenwald MJ. Clinical suppression and amblyopia. Invest Ophthalmol Vis Sci. 1988 Mar;29(3):444-51.
- Results publication: 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.
- Results publicationVon Noorden GK. Binocular vision and ocular motility. Theory and Management of Strabismus. 1996.
- Results publication: 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.
- Results publication: 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.
- Results publication: 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.
- Results publication: 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.
- Results publication: PubMed 11919632Kind PC, Mitchell DE, Ahmed B, Blakemore C, Bonhoeffer T, Sengpiel F. Correlated binocular activity guides recovery from monocular deprivation. Nature. 2002 Mar 28;416(6879):430-3. doi: 10.1038/416430a.
- 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. This study is not recruiting at the moment.
Wen Wen, MD, PhD study chair
Eye & ENT Hospital of Fudan University, Shanghai, China
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 and Amblyopia Functional, 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 8 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: under way, not looking for participants, as of the sponsor's last update on 26 Nov 2024. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in visual acuity at far (time frame: 1 week, 1month, 3month, 6month). 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 NCT06704737, which also lists 13 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 26 Nov 2024; AzTrials last refreshed its copy on 5 Nov 2026.