A Comparative Study Between Dissociative Treatment and Binocular Interactive Treatment in Amblyopia

NCT03255707 | Completed

• 1 other identifier: FMASU MD 293/2016
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Amblyopia is a unilateral or, infrequently, a bilateral reduction of best corrected visual acuity which cannot be attributed to coexisting eye or visual pathway disease. Amblyopia can be due to eye-crossing occurring in early childhood or due to error of refraction whether a high difference between the two eyes or very high bilateral refractive errors.Another cause could be visual deprivation like the presence of congenital cataract. The prevalence of amblyopia worldwide is approximately 1%-5% .In Egypt, a study that was held in Upper Egypt, found that the prevalence of amblyopia was 1.49%, which is higher in rural areas than in urban areas. Several modalities of treatment for amblyopia are available, yet occlusion treatment is the gold standard involving covering the good eye with a patch for a prescribed period of time ranging from 10 minutes daily to all waking hours. However, its effectiveness decreases in older children and adults. Disadvantages include prolonged treatment leading to poor compliance, patching related distress, relationship strain and stigma. In extreme cases, non-compliance with patching results in a costly hospital admission to supervise the patching treatment. In addition, wearing a patch eliminates any advantage of binocularity. Not to mention that not all patients respond to patching and of those who do, many have residual amblyopia after treatment is stopped regardless of compliance. More importantly, binocular vision is not automatically restored once the vision in the amblyopic eye has been improved. In fact, once the patch is removed after therapy, the amblyopic eye could be suppressed by the better seeing eye and can lose some of the gains achieved as a result of therapy. Another modality of treatment is atropine eye drops and optical penalisation which are usually secondary treatments to failed patching but carrying the same disadvantages as the ordinary patching. Advances in amblyopia treatment include dichoptic training, perceptual learning, and video gaming. These depend on the fact that the adult brain has been shown to be much more plastic than it was once believed to be and hence have the advantage of expanding the age of response in adults. Perceptual learning approaches have the advantage of being a dichoptic (binocular treatment using both eyes) approach which is independent of age and type of amblyopia. A step further to conventional treatment is the use of a home-based approach allowing remote internet monitoring of treatment between office visits and hence better compliance. In addition a video game version of the treatment is developed to make it more enjoyable for improving compliance. Our goal is to compare the outcome between the gold standard occlusion therapy and one of the dichoptic treatments.

Conditions

Amblyopia

Keywords

Amblyopia; Interactive Binocular Treatment; Dissociative Treatment; Occlusion; Patching

Outcome Measures

Primary Outcomes (1)

• visual acuity

  Best corrected visual acuity in the amblyopic eye

  6 months

Secondary Outcomes (2)

• Compliance

  6 months

• crowding ratio

  6 months

Study Arms (2)

Group A

EXPERIMENTAL

50 patients will receive the gold standard occlusion therapy

Device: eye patch

Group B

EXPERIMENTAL

50 patients will receive dichoptic treatment in the form of playing a video game (Lazy Eye Blocks ®) while wearing a red/green goggle.

Device: dichoptic treatment

Interventions

eye patch DEVICE

Occluding the better seeing eye for a given number of hours daily

Group A

dichoptic treatment DEVICE

dichoptic treatment in the form of playing a video game (Lazy Eye Blocks ®) while wearing a red/green goggle.

Group B

Eligibility Criteria

• Age: 4 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Any degree of amblyopia
• Orthotropia in primary position.

You may not qualify if:

• Any ocular disease affecting vision
• Angle of deviation in primary position (Heterotropia)
• Adult patients and children's parents unwilling to enter or complete the study
• Ignorance of patients to use the video game

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals (Demerdash)

Cairo, Egypt

Location

Related Publications (29)

• Aldebasi YH. Prevalence of amblyopia in primary school children in Qassim province, Kingdom of Saudi Arabia. Middle East Afr J Ophthalmol. 2015 Jan-Mar;22(1):86-91. doi: 10.4103/0974-9233.148355.

  PMID: 25624680 BACKGROUND

• Attebo K, Mitchell P, Cumming R, Smith W, Jolly N, Sparkes R. Prevalence and causes of amblyopia in an adult population. Ophthalmology. 1998 Jan;105(1):154-9. doi: 10.1016/s0161-6420(98)91862-0.

  PMID: 9442792 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

• Ding J, Klein SA, Levi DM. Binocular combination in abnormal binocular vision. J Vis. 2013 Feb 8;13(2):14. doi: 10.1167/13.2.14.

  PMID: 23397039 BACKGROUND

• Ding J, Levi DM. Rebalancing binocular vision in amblyopia. Ophthalmic Physiol Opt. 2014 Mar;34(2):199-213. doi: 10.1111/opo.12115. Epub 2014 Jan 12.

  PMID: 24417338 BACKGROUND

• Dixon-Woods M, Awan M, Gottlob I. Why is compliance with occlusion therapy for amblyopia so hard? A qualitative study. Arch Dis Child. 2006 Jun;91(6):491-4. doi: 10.1136/adc.2005.090373. Epub 2006 Mar 10.

  PMID: 16531452 BACKGROUND

• Fu J, Li SM, Liu LR, Li JL, Li SY, Zhu BD, Li H, Yang Z, Li L, Wang NL; Anyang Childhood Eye Study Group. Prevalence of amblyopia and strabismus in a population of 7th-grade junior high school students in Central China: the Anyang Childhood Eye Study (ACES). Ophthalmic Epidemiol. 2014 Jun;21(3):197-203. doi: 10.3109/09286586.2014.904371. Epub 2014 Apr 17.

  PMID: 24742059 BACKGROUND

• Ganekal S, Jhanji V, Liang Y, Dorairaj S. Prevalence and etiology of amblyopia in Southern India: results from screening of school children aged 5-15 years. Ophthalmic Epidemiol. 2013 Aug;20(4):228-31. doi: 10.3109/09286586.2013.809772.

  PMID: 23865603 BACKGROUND

• He HY, Hodos W, Quinlan EM. Visual deprivation reactivates rapid ocular dominance plasticity in adult visual cortex. J Neurosci. 2006 Mar 15;26(11):2951-5. doi: 10.1523/JNEUROSCI.5554-05.2006.

  PMID: 16540572 BACKGROUND

• Hess RF, Babu RJ, Clavagnier S, Black J, Bobier W, Thompson B. The iPod binocular home-based treatment for amblyopia in adults: efficacy and compliance. Clin Exp Optom. 2014 Sep;97(5):389-98. doi: 10.1111/cxo.12192. Epub 2014 Aug 18.

  PMID: 25131694 BACKGROUND

• Hess RF, Mansouri B, Thompson B. Restoration of binocular vision in amblyopia. Strabismus. 2011 Sep;19(3):110-8. doi: 10.3109/09273972.2011.600418.

  PMID: 21870914 BACKGROUND

• Levi DM, Li RW. Perceptual learning as a potential treatment for amblyopia: a mini-review. Vision Res. 2009 Oct;49(21):2535-49. doi: 10.1016/j.visres.2009.02.010. Epub 2009 Feb 27.

  PMID: 19250947 BACKGROUND

• Mansouri B, Thompson B, Hess RF. Measurement of suprathreshold binocular interactions in amblyopia. Vision Res. 2008 Dec;48(28):2775-84. doi: 10.1016/j.visres.2008.09.002. Epub 2008 Nov 1.

  PMID: 18809424 BACKGROUND

• Oscar A, Cherninkova S, Haykin V, Aroyo A, Levi A, Marinov N, Kostova S, Elenkov C, Veleva N, Chernodrinska V, Petkova I, Spitzer J. Amblyopia screening in Bulgaria. J Pediatr Ophthalmol Strabismus. 2014 Sep-Oct;51(5):284-8. doi: 10.3928/01913913-20140618-01. Epub 2014 Jun 25.

  PMID: 24971584 BACKGROUND

• Scheiman MM, Hertle RW, Beck RW, Edwards AR, Birch E, Cotter SA, Crouch ER Jr, Cruz OA, Davitt BV, Donahue S, Holmes JM, Lyon DW, Repka MX, Sala NA, Silbert DI, Suh DW, Tamkins SM; Pediatric Eye Disease Investigator Group. Randomized trial of treatment of amblyopia in children aged 7 to 17 years. Arch Ophthalmol. 2005 Apr;123(4):437-47. doi: 10.1001/archopht.123.4.437.

  PMID: 15824215 BACKGROUND

• Pizzorusso T, Medini P, Berardi N, Chierzi S, Fawcett JW, Maffei L. Reactivation of ocular dominance plasticity in the adult visual cortex. Science. 2002 Nov 8;298(5596):1248-51. doi: 10.1126/science.1072699.

  PMID: 12424383 BACKGROUND

• Polat U, Ma-Naim T, Belkin M, Sagi D. Improving vision in adult amblyopia by perceptual learning. Proc Natl Acad Sci U S A. 2004 Apr 27;101(17):6692-7. doi: 10.1073/pnas.0401200101. Epub 2004 Apr 19.

  PMID: 15096608 BACKGROUND

• Stewart CE, Fielder AR, Stephens DA, Moseley MJ. Treatment of unilateral amblyopia: factors influencing visual outcome. Invest Ophthalmol Vis Sci. 2005 Sep;46(9):3152-60. doi: 10.1167/iovs.05-0357.

  PMID: 16123414 BACKGROUND

• VON NOORDEN G. Principles of surgical treatment. Binocular vision and ocular motility. 1985:440-79.

  BACKGROUND

• Abdelrazik ST, Khalil MF. Prevalence of amblyopia among children attending primary schools during the amblyogenic period in Minia county. Journal of the Egyptian Ophthalmological Society. 2014 Oct 1;107(4):220.

  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

• Bi H, Zhang B, Tao X, Harwerth RS, Smith EL 3rd, Chino YM. Neuronal responses in visual area V2 (V2) of macaque monkeys with strabismic amblyopia. Cereb Cortex. 2011 Sep;21(9):2033-45. doi: 10.1093/cercor/bhq272. Epub 2011 Jan 24.

  PMID: 21263036 BACKGROUND

• Foss AJ, Gregson RM, MacKeith D, Herbison N, Ash IM, Cobb SV, Eastgate RM, Hepburn T, Vivian A, Moore D, Haworth SM; I-BiT Steering group. Evaluation and development of a novel binocular treatment (I-BiT) system using video clips and interactive games to improve vision in children with amblyopia ('lazy eye'): study protocol for a randomised controlled trial. Trials. 2013 May 20;14:145. doi: 10.1186/1745-6215-14-145.

  PMID: 23688108 BACKGROUND

• Hess RF, Mansouri B, Thompson B. A new binocular approach to the treatment of amblyopia in adults well beyond the critical period of visual development. Restor Neurol Neurosci. 2010;28(6):793-802. doi: 10.3233/RNN-2010-0550.

  PMID: 21209494 BACKGROUND

• Hess RF, Thompson B, Baker DH. Binocular vision in amblyopia: structure, suppression and plasticity. Ophthalmic Physiol Opt. 2014 Mar;34(2):146-62. doi: 10.1111/opo.12123.

  PMID: 24588532 BACKGROUND

• Maehara G, Thompson B, Mansouri B, Farivar R, Hess RF. The perceptual consequences of interocular suppression in amblyopia. Invest Ophthalmol Vis Sci. 2011 Nov 21;52(12):9011-7. doi: 10.1167/iovs.11-7748.

  PMID: 22025565 BACKGROUND

• American Academy of Ophthalmology Basic and Clinical Science Course Subcommittee. Basic and Clinical Science Course. Pediatric Ophthalmology and Strabismus: Section 6. San Francisco, CA: American Academy of Ophthalmology. 2012.pp.61.

  BACKGROUND

• Ophthalmology P. Strabismus Preferred Practice Pattern Panel. Amblyopia Preferred Practice Pattern Guidelines. San Francisco, CA: American Academy of Ophthamology. 2012

  BACKGROUND

• Tsirlin I, Colpa L, Goltz HC, Wong AM. Behavioral Training as New Treatment for Adult Amblyopia: A Meta-Analysis and Systematic Review. Invest Ophthalmol Vis Sci. 2015 Jun;56(6):4061-75. doi: 10.1167/iovs.15-16583.

  PMID: 26114483 BACKGROUND

MeSH Terms

Conditions

Amblyopia; Bites and Stings

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• Hazem H Nouh, MD

  Ophthalmology department, faculty of medicine, Ain Shams University

  STUDY CHAIR

• Mohammad A Rashad, MD

  Ophthalmology department, faculty of medicine, Ain Shams University

  STUDY CHAIR

• Walid M El-Zawahry, MD

  Ophthalmology department, faculty of medicine, Ain Shams University

  STUDY DIRECTOR

• Ahmad T Ismail, MD

  Ophthalmology department, faculty of medicine, Ain Shams University

  STUDY DIRECTOR

• Suha A Hussein, M.Sc

  Ophthalmology department, faculty of medicine, Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ophthalmology Specialist

Model Details: Patients of the study will be recruited from the ophthalmology outpatient clinic of Ain Shams University Hospital.100 patients of both sexes with amblyopia will be enrolled. Informed consents will be obtained from adult patients and children's parents. Patients will be assigned randomly: Group A:50 patients will receive the gold standard occlusion therapy while playing a video game (Lazy Eye Tetris games such as Lazy Eye Blocks ®).Group B:50 patients will receive dichoptic treatment in the form of playing a video game (Lazy Eye Tetris games such as Lazy Eye Blocks ®) while wearing a red/green goggle.Each group will be subdivided according to age: 1)4 to 7 years. 2)\>7 to 12 years. 3)\>12 to 30 years. Hours of occlusion /dichoptic treatment will be classified according to the degree of amblyopia: * Mild to moderate amblyopia (Best corrected visual acuity (BCVA)\< 0.2) : 2-4 hours * Severe (BCVA\> 0.2) : 4-6 hours All patients will undergo full ophthalmological examination

Study Record Dates

• First Submitted: August 6, 2017
• First Posted: August 21, 2017
• Study Start: November 24, 2016
• Primary Completion: November 27, 2022
• Study Completion: November 27, 2022
• Last Updated: November 29, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)