Non-invasive Induction of Metaplasticity for Amblyopia

NCT07846397 | Not Yet Recruiting

• 1 other identifier: IRB-P00051936
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to determine the efficacy of flicker therapy as an adjunct therapy to treat amblyopia beyond the critical period in adolescents and adults aged 14-40 years who have amblyopia of ≥3 lines of interocular best-corrected (with glasses) visual acuity difference. The main questions it aims to answer are:

• Does flicker therapy enable clinically meaningful and durable visual recovery from amblyopia?
• Do flicker therapy-treated patients show a change in amblyopic eye visual acuity (lines)? Participants will undergo daily flicker therapy for 1 hour per day.

Conditions

Amblyopia; Amblyopia Unilateral; Amblyopia, Anisometropic; Amblyopia Strabismic

Keywords

Amblyopia; Flicker therapy; Pediatric; Lazy eye; Visual acuity; Visual impairment; critical period; adults; adolescents; ophthalmology

Outcome Measures

Primary Outcomes (1)

• Amblyopic Eye Best-Corrected Visual Acuity (BCVA)

  Change in visual acuity of the amblyopic eye after 8 weeks of flicker treatment

  From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (5)

• Proportion of patients with resolved amblyopia

  8 weeks

• Durability of amblyopic eye visual acuity response

  From end of treatment at 8 weeks to end of follow-up at 16 weeks

• Change in stereoacuity

  8 weeks and 16 weeks

• Quality of life measures using the Amblyopia & Strabismis Questionnaire

  Change from baseline at 8 weeks and 16 weeks

• Tolerability and Safety of Flicker Therapy

  Assessed throughout the study duration at 1,2, 4, 6, 8, 9, 10, 12, 14 and 16 weeks

Study Arms (1)

Arm 1 - Flicker Therapy

EXPERIMENTAL

Participants will be required to use the VistaSync Visual Stimulation System VTX100 for 1 hours daily throughout the 8-week study period. At the mid-point 4-week study visit, the dose may be escalated to 2 hours daily, as investigator sees fit. This regimen aims to improve visual acuity in the amblyopic eye by encouraging its use. Compliance with the this protocol will be monitored, and participants will be provided with instructions and support to ensure proper device usage and adherence to the treatment.

Device: Flicker

Interventions

Flicker DEVICE

The device is intended for investigational use in children (14 years old and up) and adults with amblyopia to evaluate the once daily use (up to 2 hours) over the study period of 8 weeks. Key characteristics of the system include: * Non-implantable * Externally applied * No electrical stimulation delivered to the body * No invasive components or procedures * No life-sustaining or life-supporting function The device consists of a handheld, battery-powered controller, an eyeset, and a power charger. The device is intended for daily use at home.

Arm 1 - Flicker Therapy

Eligibility Criteria

• Age: 14 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age ≥14 and ≤40 years
• Amblyopia associated with strabismus and/or anisometropia
• Criteria for strabismus: must meet at least one of the following: heterotropia at distance and/or near with or without spectacle correction, history of strabismus surgery, documented history of strabismus that is no longer present and felt by the investigator could have caused the amblyopia
• Criteria for anisometropia: must meet at least one of the following:
• ≥ 0.50 D difference in spherical equivalent between eyes
• ≥ 1.50 D difference in astigmatism in any meridian between the eyes
• Visual acuity measured in each eye within 7 days prior to enrollment using ETDRS protocol on a study certified visual acuity tester as follows:
• Amblyopic eye visual acuity of 20/40 - 20/400
• Fellow eye visual acuity of ≥ 20/25.
• Spectacle correction for measurement of enrollment visual acuity must meet the following criteria and be based on a cycloplegic refraction \< 6 months old:
• Requirement for spectacle correction:
• Spherical equivalent must be within 0.50 D of fully correcting anisometropia
• Hyperopia ≥ 3.00 D must be corrected
• Hyperopia may not be under-corrected by \>1.50 D spherical equivalent and must be symmetrically reduced in each eye
• Cylinder power must be within 0.50 D of fully correcting the astigmatism

You may not qualify if:

• Myopia \> -6.00 D spherical equivalent
• Presence of associated findings that could cause reduced visual acuity
• Nystagmus does not exclude the subject if the above visual acuity criteria are met
• Treatment with topical atropine within the past 12 weeks
• Previous intraocular or refractive surgery
• Strabismus surgery planned within 16 weeks
• Current vision therapy or orthoptics
• History of seizures
• Known past or present susceptibility to seizures at the discretion of the investigator
• Known past or present psychological problems
• Known contraindications or inability to use of a head-mounted device (over one's glasses) and/or exposure to flickering light
• Current use of medication for the treatment of seizures, bipolar disorder, or migraine
• Use of any medication with neuromodulatory effects, including
• Medications that reduce seizure thresholds

Sponsors & Collaborators

• Massachusetts Institute of Technology: collaborator
• Boston Children's Hospital: lead

Related Publications (53)

• Birch EE, Morale SE, Jost RM, De La Cruz A, Kelly KR, Wang YZ, Bex PJ. Assessing Suppression in Amblyopic Children With a Dichoptic Eye Chart. Invest Ophthalmol Vis Sci. 2016 Oct 1;57(13):5649-5654. doi: 10.1167/iovs.16-19986.

  PMID: 27784068 BACKGROUND

• Wu C, Gaier ED, Nihalani BR, Whitecross S, Hensch TK, Hunter DG. Durable recovery from amblyopia with donepezil. Sci Rep. 2023 Jun 22;13(1):10161. doi: 10.1038/s41598-023-34891-5.

  PMID: 37349338 BACKGROUND

• Kelly KR, Jost RM, Wang YZ, Dao L, Beauchamp CL, Leffler JN, Birch EE. Improved Binocular Outcomes Following Binocular Treatment for Childhood Amblyopia. Invest Ophthalmol Vis Sci. 2018 Mar 1;59(3):1221-1228. doi: 10.1167/iovs.17-23235.

  PMID: 29625442 BACKGROUND

• Sharif MH, Talebnejad MR, Rastegar K, Khalili MR, Nowroozzadeh MH. Oral fluoxetine in the management of amblyopic patients aged between 10 and 40 years old: a randomized clinical trial. Eye (Lond). 2019 Jul;33(7):1060-1067. doi: 10.1038/s41433-019-0360-z. Epub 2019 Feb 19.

  PMID: 30783259 BACKGROUND

• Reilly-Andujar F, Cramer TLM, Wang EY, Chang NW, Chang YW, Heynen AJ, Bear MF. Tuning metaplasticity in the adult visual cortex using flickering light. bioRxiv [Preprint]. 2026 Feb 18:2026.02.16.706197. doi: 10.64898/2026.02.16.706197.

  PMID: 41757096 BACKGROUND

• Kirkwood A, Rioult MC, Bear MF. Experience-dependent modification of synaptic plasticity in visual cortex. Nature. 1996 Jun 6;381(6582):526-8. doi: 10.1038/381526a0.

  PMID: 8632826 BACKGROUND

• Muller-Dahlhaus F, Ziemann U. Metaplasticity in human cortex. Neuroscientist. 2015 Apr;21(2):185-202. doi: 10.1177/1073858414526645. Epub 2014 Mar 11.

  PMID: 24620008 BACKGROUND

• Zhou X, He Y, Xu T, Wu Z, Guo W, Xu X, Liu Y, Zhang Y, Shang H, Huang L, Yao Z, Li Z, Su L, Li Z, Feng T, Zhang S, Monteiro O, Cunha RA, Huang ZL, Zhang K, Li Y, Cai X, Qu J, Chen JF. 40 Hz light flickering promotes sleep through cortical adenosine signaling. Cell Res. 2024 Mar;34(3):214-231. doi: 10.1038/s41422-023-00920-1. Epub 2024 Feb 8.

  PMID: 38332199 BACKGROUND

• Schiel R, Vilser W, Kovar F, Kramer G, Braun A, Stein G. Retinal vessel response to flicker light in children and adolescents with type 1 diabetes mellitus and overweight or obesity. Diabetes Res Clin Pract. 2009 Mar;83(3):358-64. doi: 10.1016/j.diabres.2008.11.001. Epub 2008 Dec 18.

  PMID: 19100645 BACKGROUND

• Chan D, de Weck G, Jackson BL, Suk HJ, Milman NP, Kitchener E, Avalos VSF, Quay MJ, Aoki K, Ruiz E, Becker A, Zheng M, Philips R, Firenze R, Geigenmuller U, Hammerschlag B, Arnold S, Kivisakk P, Brickhouse M, Touroutoglou A, Brown EN, Boyden ES, Dickerson BC, Klerman EB, Tsai LH. Gamma sensory stimulation in mild Alzheimer's dementia: An open-label extension study. Alzheimers Dement. 2025 Oct;21(10):e70792. doi: 10.1002/alz.70792.

  PMID: 41137616 BACKGROUND

• Chan D, Suk HJ, Jackson BL, Milman NP, Stark D, Klerman EB, Kitchener E, Fernandez Avalos VS, de Weck G, Banerjee A, Beach SD, Blanchard J, Stearns C, Boes AD, Uitermarkt B, Gander P, Howard M 3rd, Sternberg EJ, Nieto-Castanon A, Anteraper S, Whitfield-Gabrieli S, Brown EN, Boyden ES, Dickerson BC, Tsai LH. Gamma frequency sensory stimulation in mild probable Alzheimer's dementia patients: Results of feasibility and pilot studies. PLoS One. 2022 Dec 1;17(12):e0278412. doi: 10.1371/journal.pone.0278412. eCollection 2022.

  PMID: 36454969 BACKGROUND

• Echavarri-Leet MP, Resnick HH, Bowen DA, Goss D, Bear MF, Gaier ED. Spontaneous recovery from amblyopia following fellow eye vision loss: a systematic review and narrative synthesis. J AAPOS. 2024 Aug;28(4):103971. doi: 10.1016/j.jaapos.2024.103971. Epub 2024 Jul 14.

  PMID: 39009183 BACKGROUND

• Amanat M, Togha M, Agah E, Ramezani M, Tavasoli AR, Azizi Malamiri R, Fashandaky F, Heidari M, Salehi M, Eshaghi H, Ashrafi MR. Cinnarizine and sodium valproate as the preventive agents of pediatric migraine: A randomized double-blind placebo-controlled trial. Cephalalgia. 2020 Jun;40(7):665-674. doi: 10.1177/0333102419888485. Epub 2019 Nov 10.

  PMID: 31707814 BACKGROUND

• Hiilesmaa VK, Bardy AH, Granstrom ML, Teramo KA. Valproic acid during pregnancy. Lancet. 1980 Apr 19;1(8173):883. doi: 10.1016/s0140-6736(80)91387-2. No abstract available.

  PMID: 6103246 BACKGROUND

• Nau H, Hauck RS, Ehlers K. Valproic acid-induced neural tube defects in mouse and human: aspects of chirality, alternative drug development, pharmacokinetics and possible mechanisms. Pharmacol Toxicol. 1991 Nov;69(5):310-21. doi: 10.1111/j.1600-0773.1991.tb01303.x.

  PMID: 1803343 BACKGROUND

• Cotariu D, Zaidman JL. Developmental toxicity of valproic acid. Life Sci. 1991;48(14):1341-50. doi: 10.1016/0024-3205(91)90430-j.

  PMID: 2008152 BACKGROUND

• Mattson RH, Cramer JA, Williamson PD, Novelly RA. Valproic acid in epilepsy: clinical and pharmacological effects. Ann Neurol. 1978 Jan;3(1):20-5. doi: 10.1002/ana.410030105.

  PMID: 350128 BACKGROUND

• Tomson T, Marson A, Boon P, Canevini MP, Covanis A, Gaily E, Kalviainen R, Trinka E. Valproate in the treatment of epilepsy in girls and women of childbearing potential. Epilepsia. 2015 Jul;56(7):1006-19. doi: 10.1111/epi.13021. Epub 2015 May 16.

  PMID: 25851171 BACKGROUND

• Pediatric Eye Disease Investigator Group; Repka MX, Kraker RT, Dean TW, Beck RW, Siatkowski RM, Holmes JM, Beauchamp CL, Golden RP, Miller AM, Verderber LC, Wallace DK. A randomized trial of levodopa as treatment for residual amblyopia in older children. Ophthalmology. 2015 May;122(5):874-81. doi: 10.1016/j.ophtha.2015.01.002. Epub 2015 Feb 9.

  PMID: 25676904 BACKGROUND

• Morrison DG, Heidary G, Chang MY, Binenbaum G, Cavuoto KM, Galvin J, Trivedi R, Kim SJ, Pineles SL. Levodopa/Carbidopa to Augment the Treatment of Amblyopia: A Report by the American Academy of Ophthalmology. Ophthalmology. 2023 Nov;130(11):1221-1227. doi: 10.1016/j.ophtha.2023.07.008. Epub 2023 Aug 29.

  PMID: 37642618 BACKGROUND

• Yang EJ, Lin EW, Hensch TK. Critical period for acoustic preference in mice. Proc Natl Acad Sci U S A. 2012 Oct 16;109 Suppl 2(Suppl 2):17213-20. doi: 10.1073/pnas.1200705109. Epub 2012 Oct 8.

  PMID: 23045690 BACKGROUND

• Gervain J, Vines BW, Chen LM, Seo RJ, Hensch TK, Werker JF, Young AH. Valproate reopens critical-period learning of absolute pitch. Front Syst Neurosci. 2013 Dec 3;7:102. doi: 10.3389/fnsys.2013.00102. eCollection 2013.

  PMID: 24348349 BACKGROUND

• Lennartsson A, Arner E, Fagiolini M, Saxena A, Andersson R, Takahashi H, Noro Y, Sng J, Sandelin A, Hensch TK, Carninci P. Remodeling of retrotransposon elements during epigenetic induction of adult visual cortical plasticity by HDAC inhibitors. Epigenetics Chromatin. 2015 Dec 14;8:55. doi: 10.1186/s13072-015-0043-3. eCollection 2015.

  PMID: 26673794 BACKGROUND

• Shmal D, Mantero G, Floss T, Benfenati F, Maya-Vetencourt JF. Restoring vision in adult amblyopia by enhancing plasticity through deletion of the transcriptional repressor REST. iScience. 2024 Mar 14;27(4):109507. doi: 10.1016/j.isci.2024.109507. eCollection 2024 Apr 19.

  PMID: 38591011 BACKGROUND

• Silingardi D, Scali M, Belluomini G, Pizzorusso T. Epigenetic treatments of adult rats promote recovery from visual acuity deficits induced by long-term monocular deprivation. Eur J Neurosci. 2010 Jun;31(12):2185-92. doi: 10.1111/j.1460-9568.2010.07261.x. Epub 2010 Jun 14.

  PMID: 20550570 BACKGROUND

• Putignano E, Lonetti G, Cancedda L, Ratto G, Costa M, Maffei L, Pizzorusso T. Developmental downregulation of histone posttranslational modifications regulates visual cortical plasticity. Neuron. 2007 Mar 1;53(5):747-59. doi: 10.1016/j.neuron.2007.02.007.

  PMID: 17329213 BACKGROUND

• Monti B, Polazzi E, Contestabile A. Biochemical, molecular and epigenetic mechanisms of valproic acid neuroprotection. Curr Mol Pharmacol. 2009 Jan;2(1):95-109. doi: 10.2174/1874467210902010095.

  PMID: 20021450 BACKGROUND

• Penney J, Tsai LH. Histone deacetylases in memory and cognition. Sci Signal. 2014 Dec 9;7(355):re12. doi: 10.1126/scisignal.aaa0069.

  PMID: 25492968 BACKGROUND

• Gaier ED, Hunter DG. Advances in Amblyopia Treatment: Paradigm Shifts and Future Directions. Int Ophthalmol Clin. 2017 Fall;57(4):117-128. doi: 10.1097/IIO.0000000000000184. No abstract available.

  PMID: 28885251 BACKGROUND

• Multi-ethnic Pediatric Eye Disease Study Group. Prevalence of amblyopia and strabismus in African American and Hispanic children ages 6 to 72 months the multi-ethnic pediatric eye disease study. Ophthalmology. 2008 Jul;115(7):1229-1236.e1. doi: 10.1016/j.ophtha.2007.08.001. Epub 2007 Oct 22.

  PMID: 17953989 BACKGROUND

• Friedman DS, Repka MX, Katz J, Giordano L, Ibironke J, Hawse P, Tielsch JM. Prevalence of amblyopia and strabismus in white and African American children aged 6 through 71 months the Baltimore Pediatric Eye Disease Study. Ophthalmology. 2009 Nov;116(11):2128-34.e1-2. doi: 10.1016/j.ophtha.2009.04.034. Epub 2009 Sep 16.

  PMID: 19762084 BACKGROUND

• Huttunen HJ, Palva JM, Lindberg L, Palva S, Saarela V, Karvonen E, Latvala ML, Liinamaa J, Booms S, Castren E, Uusitalo H. Fluoxetine does not enhance the effect of perceptual learning on visual function in adults with amblyopia. Sci Rep. 2018 Aug 27;8(1):12830. doi: 10.1038/s41598-018-31169-z.

  PMID: 30150750 BACKGROUND

• Chung STL, Li RW, Silver MA, Levi DM. Donepezil Does Not Enhance Perceptual Learning in Adults with Amblyopia: A Pilot Study. Front Neurosci. 2017 Aug 7;11:448. doi: 10.3389/fnins.2017.00448. eCollection 2017.

  PMID: 28824369 BACKGROUND

• Repka MX, Kraker RT, Beck RW, Atkinson CS, Bacal DA, Bremer DL, Davis PL, Gearinger MD, Glaser SR, Hoover DL, Laby DM, Morrison DG, Rogers DL, Sala NA, Suh DW, Wheeler MB; Pediatric Eye Disease Investigator Group. Pilot study of levodopa dose as treatment for residual amblyopia in children aged 8 years to younger than 18 years. Arch Ophthalmol. 2010 Sep;128(9):1215-7. doi: 10.1001/archophthalmol.2010.178. No abstract available.

  PMID: 20837811 BACKGROUND

• Procianoy E, Fuchs FD, Procianoy L, Procianoy F. The effect of increasing doses of levodopa on children with strabismic amblyopia. J AAPOS. 1999 Dec;3(6):337-40. doi: 10.1016/s1091-8531(99)70041-8.

  PMID: 10613576 BACKGROUND

• Mohan K, Dhankar V, Sharma A. Visual acuities after levodopa administration in amblyopia. J Pediatr Ophthalmol Strabismus. 2001 Mar-Apr;38(2):62-7; quiz 96-7. doi: 10.3928/0191-3913-20010301-05.

  PMID: 11310708 BACKGROUND

• Leguire LE, Walson PD, Rogers GL, Bremer DL, McGregor ML. Levodopa/carbidopa treatment for amblyopia in older children. J Pediatr Ophthalmol Strabismus. 1995 May-Jun;32(3):143-51. doi: 10.3928/0191-3913-19950501-05.

  PMID: 7636693 BACKGROUND

• Leguire LE, Walson PD, Rogers GL, Bremer DL, McGregor ML. Longitudinal study of levodopa/carbidopa for childhood amblyopia. J Pediatr Ophthalmol Strabismus. 1993 Nov-Dec;30(6):354-60. doi: 10.3928/0191-3913-19931101-04.

  PMID: 8120739 BACKGROUND

• Leguire LE, Rogers GL, Walson PD, Bremer DL, McGregor ML. Occlusion and levodopa-carbidopa treatment for childhood amblyopia. J AAPOS. 1998 Oct;2(5):257-64. doi: 10.1016/s1091-8531(98)90080-5.

  PMID: 10646745 BACKGROUND

• Chatzistefanou KI, Mills MD. The role of drug treatment in children with strabismus and amblyopia. Paediatr Drugs. 2000 Mar-Apr;2(2):91-100. doi: 10.2165/00148581-200002020-00002.

  PMID: 10937461 BACKGROUND

• Bhartiya P, Sharma P, Biswas NR, Tandon R, Khokhar SK. Levodopa-carbidopa with occlusion in older children with amblyopia. J AAPOS. 2002 Dec;6(6):368-72. doi: 10.1067/mpa.2002.129043.

  PMID: 12506278 BACKGROUND

• Birch EE. Amblyopia and binocular vision. Prog Retin Eye Res. 2013 Mar;33:67-84. doi: 10.1016/j.preteyeres.2012.11.001. Epub 2012 Nov 29.

  PMID: 23201436 BACKGROUND

• Holmes JM, Beck RW, Kraker RT, Astle WF, Birch EE, Cole SR, Cotter SA, Donahue S, Everett DF, Hertle RW, Keech RV, Paysse E, Quinn GF, Repka MX, Scheiman MM; Pediatric Eye Disease Investigator Group. Risk of amblyopia recurrence after cessation of treatment. J AAPOS. 2004 Oct;8(5):420-8. doi: 10.1016/S1091853104001612.

  PMID: 15492733 BACKGROUND

• 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 BACKGROUND

• Jost RM, Hudgins LA, Dao LM, Stager DR Jr, Luu B, Beauchamp CL, Hunter JS, Giridhar P, Wang YZ, Birch EE. Randomized clinical trial of streaming dichoptic movies versus patching for treatment of amblyopia in children aged 3 to 7 years. Sci Rep. 2022 Mar 9;12(1):4157. doi: 10.1038/s41598-022-08010-9.

  PMID: 35264692 BACKGROUND

• Wygnanski-Jaffe T, Kushner BJ, Moshkovitz A, Belkin M, Yehezkel O; CureSight Pivotal Trial Group. An Eye-Tracking-Based Dichoptic Home Treatment for Amblyopia: A Multicenter Randomized Clinical Trial. Ophthalmology. 2023 Mar;130(3):274-285. doi: 10.1016/j.ophtha.2022.10.020. Epub 2022 Oct 26.

  PMID: 36306974 BACKGROUND

• Wallace DK, Lazar EL, Melia M, Birch EE, Holmes JM, Hopkins KB, Kraker RT, Kulp MT, Pang Y, Repka MX, Tamkins SM, Weise KK; Pediatric Eye Disease Investigator Group. Stereoacuity in children with anisometropic amblyopia. J AAPOS. 2011 Oct;15(5):455-61. doi: 10.1016/j.jaapos.2011.06.007.

  PMID: 22108357 BACKGROUND

• Stewart CE, Wallace MP, Stephens DA, Fielder AR, Moseley MJ; MOTAS Cooperative. The effect of amblyopia treatment on stereoacuity. J AAPOS. 2013 Apr;17(2):166-73. doi: 10.1016/j.jaapos.2012.10.021.

  PMID: 23622448 BACKGROUND

• Giaschi D, Chapman C, Meier K, Narasimhan S, Regan D. The effect of occlusion therapy on motion perception deficits in amblyopia. Vision Res. 2015 Sep;114:122-34. doi: 10.1016/j.visres.2015.05.015. Epub 2015 Jun 4.

  PMID: 26049038 BACKGROUND

• Pediatric Eye Disease Investigator Group Writing Committee; Rutstein RP, Quinn GE, Lazar EL, Beck RW, Bonsall DJ, Cotter SA, Crouch ER, Holmes JM, Hoover DL, Leske DA, Lorenzana IJ, Repka MX, Suh DW. A randomized trial comparing Bangerter filters and patching for the treatment of moderate amblyopia in children. Ophthalmology. 2010 May;117(5):998-1004.e6. doi: 10.1016/j.ophtha.2009.10.014. Epub 2010 Feb 16.

  PMID: 20163869 BACKGROUND

• Holmes JM, Kraker RT, Beck RW, Birch EE, Cotter SA, Everett DF, Hertle RW, Quinn GE, Repka MX, Scheiman MM, Wallace DK; Pediatric Eye Disease Investigator Group. A randomized trial of prescribed patching regimens for treatment of severe amblyopia in children. Ophthalmology. 2003 Nov;110(11):2075-87. doi: 10.1016/j.ophtha.2003.08.001.

  PMID: 14597512 BACKGROUND

• Repka MX, Beck RW, Holmes JM, Birch EE, Chandler DL, Cotter SA, Hertle RW, Kraker RT, Moke PS, Quinn GE, Scheiman MM; Pediatric Eye Disease Investigator Group. A randomized trial of patching regimens for treatment of moderate amblyopia in children. Arch Ophthalmol. 2003 May;121(5):603-11. doi: 10.1001/archopht.121.5.603.

  PMID: 12742836 BACKGROUND

• Pediatric Eye Disease Investigator Group.. A randomized trial of atropine vs. patching for treatment of moderate amblyopia in children. Arch Ophthalmol. 2002 Mar;120(3):268-78. doi: 10.1001/archopht.120.3.268.

  PMID: 11879129 BACKGROUND

MeSH Terms

Conditions

Amblyopia; Vision Disorders

Interventions

Flicker Fusion

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Ophthalmological; Diagnostic Techniques and Procedures; Diagnosis; Ocular Physiological Phenomena

Study Officials

• Eric D Gaier, MD PhD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Eric D Gaier, MD PhD

CONTACT

617-355-6401; Eric.Gaier@childrens.harvard.edu

Chaya Manjeshwar, BS

CONTACT

Chaya.Manjeshwar@childrens.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Ophthalmology

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: September 29, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The individual participant data (IPD) and supporting information will be available to qualified researchers starting 6 months after the publication of the primary study results. The data will remain accessible for 5 years from the start date. Researchers must submit a formal request, which will be reviewed for ethical and scientific alignment. This plan ensures valuable data contributes to advancements in amblyopia treatment while maintaining confidentiality.
• Access Criteria: Who Will Be Able to Access: Qualified researchers from academic institutions, research organizations, and healthcare institutions will be able to access the IPD and supporting information. Access will be granted based on the submission and approval of a formal request. What They Will Be Able to Access: Researchers will have access to de-identified individual participant data, including: Demographic information Clinical outcomes Visual acuity measurements Stereoacuity results Quality of life assessments Adverse event reports How They Will Be Able to Access: Researchers must submit a formal request detailing their study purpose and intended use of the data. The request will be reviewed by our study team for ethical and scientific alignment. Approved researchers will be granted access to the data through a secure online repository that complies with data protection regulations.