AR Training Versus Patching in Unilateral Amblyopia

NCT06498206 | Recruiting DMC

• 1 other identifier: 2024-ARTA
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Amblyopia Unilateral

Keywords

Augmented reality training; Dichoptic therapy; Patching

Outcome Measures

Primary Outcomes (1)

• 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.

  13 weeks

Secondary Outcomes (7)

• Change in best-corrected visual acuity

  2 weeks, 4 weeks, 9 weeks, 13 weeks

• Effective rate

  2 weeks, 4 weeks, 9 weeks

• Change in habitual visual acuity

  2 weeks, 4 weeks, 9 weeks, 13 weeks

• Change in stereopsis

  2 weeks, 4 weeks, 9 weeks, 13 weeks

• Change in contrast sensitivity

  2 weeks, 4 weeks, 9 weeks, 13 weeks

Other Outcomes (2)

• Normal proportion in the worth-4 dot test

  2 weeks, 4 weeks, 9 weeks, 13 weeks

• Normal proportion in the Bagolini striated glasses test

  2 weeks, 4 weeks, 9 weeks, 13 weeks

Study Arms (2)

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.

Other: AR training

Patching group

ACTIVE COMPARATOR

Conventional patching therapy.

Other: Patching

Interventions

AR training OTHER

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.

AR training group

Patching OTHER

Conventional patching therapy.

Patching group

Eligibility Criteria

• Age: 5 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead
• First Affiliated Hospital of Fujian Medical University: collaborator
• Shanghai Tongren Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• Jiangsu Provincial People's Hospital: collaborator

Study Sites (1)

Eye & ENT Hospital of Fudan University

Shanghai, China

RECRUITING

Related Publications (12)

• 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.

  PMID: 31619356 BACKGROUND

• Cruz 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.

  PMID: 36526450 BACKGROUND

• Wen 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.

  PMID: 34910903 BACKGROUND

• 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.

  PMID: 24852148 BACKGROUND

• Von Noorden GK. Binocular vision and ocular motility. Theory and Management of Strabismus. 1996.

  BACKGROUND

• 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.

  PMID: 18547600 BACKGROUND

• Holopigian K, Blake R, Greenwald MJ. Clinical suppression and amblyopia. Invest Ophthalmol Vis Sci. 1988 Mar;29(3):444-51.

  PMID: 3343099 BACKGROUND

• Li 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.

  PMID: 21447685 BACKGROUND

• Zhou 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.

  PMID: 23608341 BACKGROUND

• Xu 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.

  PMID: 20951044 BACKGROUND

• 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.

  PMID: 23618663 BACKGROUND

• Zhou 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.

  PMID: 40598549 DERIVED

Central Study Contacts

Wen Wen, MD, PhD

CONTACT

86+(021)34233133; wenweneye@126.com

Yulian Zhou, MD

CONTACT

zyl_1208@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2024
• First Posted: July 12, 2024
• Study Start: August 31, 2024
• Primary Completion: August 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)