AR Training in Adults With Unilateral Amblyopia

NCT06704737 | Active Not Recruiting

• 1 other identifier: EENTAR20230225
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Amblyopia Unilateral; Amblyopia Functional

Keywords

Adult; Augmented reality training; Patching; Neural deficit

Outcome Measures

Primary Outcomes (1)

• 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.

  1 week, 1month, 3month, 6month

Secondary Outcomes (9)

• Change in visual acuity at near

  1 week, 1month, 3month, 6month

• Change in visual acuity with single tumbling E

  1 week, 1month, 3month, 6month

• Change in contrast sensitivity

  1 week, 1month, 3month, 6month

• Change in faxation stability

  1 week, 1month, 3month, 6month

• Change in binocular phase combination

  1 week, 1month, 3month, 6month

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 adults with unilateral amblyopia.

Device: AR training

Patching group

ACTIVE COMPARATOR

Conventional patching therapy.

Device: Patching

Interventions

AR training DEVICE

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

AR training group

Patching DEVICE

Conventional patching therapy.

Patching group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

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);
• 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.

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

Study Sites (1)

Eye & ENT Hospital of Fudan University

Shanghai, China

Location

Related Publications (13)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

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

  PMID: 3343099 RESULT

• 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 RESULT

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

  RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• Kind 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.

  PMID: 11919632 RESULT

• Bhola 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.

  PMID: 17074568 RESULT

Study Officials

• Wen Wen, MD, PhD

  Eye & ENT Hospital of Fudan University, Shanghai, China

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: November 26, 2024
• Study Start: February 25, 2023
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2024
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)