AmblyopiaNCT03255707
A Comparative Study Between Dissociative Treatment and Binocular Interactive Treatment in Amblyopia
A study testing eye patch and dichoptic treatment in people with Amblyopia, run by Ain Shams University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Amblyopia
- What is being tested?
- eye patch and dichoptic treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Nov 2016to 27 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 4 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Any degree of amblyopia
- Orthotropia in primary position.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
Introduction 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. Amblyopic eyes may have decreased contrast sensitivity and accommodation deficit. The fellow eye is not often normal but has subtle deficits.This can be explained by interocular suppression, or inhibition of the amblyopic eye by the strong eye, with psychophysical and physiological evidence.
Amblyopia can be classified as follows: 1) Strabismic occurring in early childhood 2) Refractive: a) Anisometropic b) High bilateral refractive errors 3) Visual deprivation.
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) approach which is independent of age and type of amblyopia. Furthermore, it has been shown recently that therapy promotes binocular vision by strengthening stereopsis and reducing suppression.
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.
Aim of the work:
To compare the gold standard occlusion therapy alone with dichoptic therapy
Patients and Methods:
Design:
The study will be a prospective experimental controlled study.
Patients of the study:
From the vicinity of the ophthalmology outpatient clinic of Ain Shams University Hospital, 100 patients of both sexes with amblyopia will be enrolled to this study. Informed consents will be obtained from adult patients and children's parents.
Patients will be assigned randomly into two groups:
Group A: 50 patients will receive the gold standard occlusion therapy
Group B: 50 patients will receive dichoptic treatment in the form of playing a video game (Lazy Eye Blocks ®) while wearing a red/green goggle.
Each group will be subdivided according to age:
- From 4 to 7 years.
- From above 7 to 12 years.
- From above 12 to 30 years.
Hours of occlusion will be classified according to the degree of amblyopia:
- Mild to moderate amblyopia (Best corrected visual acuity (BCVA)< 0.2): 2-4 hours occlusion
- Severe (BCVA> 0.2): 4-6 hours occlusion
Hours of dichoptic treatment in group B will be classified according to the degree of amblyopia:
- Mild to moderate amblyopia (BCVA< 0.2): 2-4 hours of treatment
- Severe (BCVA> 0.2): 4-6 hours of treatment
Methods
All patients will undergo the following:
- Full medical and ophthalmic history
- Examination:
- External Appearance:
Anomalous Head Position, globes (e.g., proptosis), lids (e.g. ptosis).
- Refraction:
With and without cyclopegia
- Visual acuity:
With and without correction using Snellen acuity chart and preferential looking test for non-verbal patients.
- Motility:
Ductions and versions (9 positions of gaze) E) Angle of deviation if any
- Fixation :
Fixation behavior (fixation preference) will be tested via base down 10 prism diopter fixation preference test.
- Quantitative Binocular vision assessment H) Anterior segment examination. I) Posterior segment examination using indirect ophthalmoscopy with a 20 diopter lens through a dilated pupil.
All patients in Group A will receive the gold standard occlusion therapy. All patients in Group B will receive dichoptic treatment
- Conditions
- Amblyopia
- Being tested
- eye patch, dichoptic treatment
- Keywords
- Amblyopia, Interactive Binocular Treatment, Dissociative Treatment, Occlusion, Patching
- Medical subject headings
- Amblyopia, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eye patchDevice
Occluding the better seeing eye for a given number of hours daily
dichoptic treatmentDevice
dichoptic treatment in the form of playing a video game (Lazy Eye Blocks ®) while wearing a red/green goggle.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 50 patients will receive the gold standard occlusion therapy Receives: 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. Receives: Device: dichoptic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual acuity
Best corrected visual acuity in the amblyopic eye
Measured: 6 months
Secondary outcomes (2)
Compliance
Compliance of the patient to treatment
Measured: 6 months
crowding ratio
crowded vs uncrowded visual acuity
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2017
- Study start24 Nov 2016
- Primary completion27 Nov 2022
- Study completion27 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for AmblyopiaStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suha Ahmed Amin, Ain Shams University
- Investigators
- Hazem H Nouh, MD, Study chair, Ophthalmology department, faculty of medicine, Ain Shams UniversityMohammad A Rashad, MD, Study chair, Ophthalmology department, faculty of medicine, Ain Shams UniversityWalid M El-Zawahry, MD, Study director, Ophthalmology department, faculty of medicine, Ain Shams UniversityAhmad T Ismail, MD, Study director, Ophthalmology department, faculty of medicine, Ain Shams UniversitySuha A Hussein, M.Sc, Principal investigator, Ophthalmology department, faculty of medicine, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03255707
- Sponsor's protocol ID
- FMASU MD 293/2016
- Status last verified
- Nov 2022
- First submitted
- 6 Aug 2017
- Last updated
- 29 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25624680Attebo 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.
PubMed 9442792Birch 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.
PubMed 23201436Ding 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.
PubMed 23397039Ding 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.
PubMed 24417338Dixon-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.
PubMed 16531452Fu 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.
PubMed 24742059Ganekal 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.
PubMed 23865603He 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.
PubMed 16540572Hess 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.
PubMed 25131694Hess RF, Mansouri B, Thompson B. Restoration of binocular vision in amblyopia. Strabismus. 2011 Sep;19(3):110-8. doi: 10.3109/09273972.2011.600418.
PubMed 21870914Levi 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.
PubMed 19250947Mansouri 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.
PubMed 18809424Oscar 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.
PubMed 24971584Scheiman 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.
PubMed 15824215
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Dissociative Treatment and Binocular Interactive Treatment in Amblyopia
- ClinicalTrials.gov ID
- NCT03255707
- Acronym / sponsor ID
- FMASU MD 293/2016
- Conditions
- Amblyopia
- Keywords
- Amblyopia, Interactive Binocular Treatment, Dissociative Treatment, Occlusion, Patching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 24 Nov 2016 (actual)
- Primary completion
- 27 Nov 2022 (actual)
- Study completion
- 27 Nov 2022 (actual)
- First posted
- 21 Aug 2017 (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.
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.
Detailed description
Introduction 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. Amblyopic eyes may have decreased contrast sensitivity and accommodation deficit. The fellow eye is not often normal but has subtle deficits.This can be explained by interocular suppression, or inhibition of the amblyopic eye by the strong eye, with psychophysical and physiological evidence.
Amblyopia can be classified as follows: 1) Strabismic occurring in early childhood 2) Refractive: a) Anisometropic b) High bilateral refractive errors 3) Visual deprivation.
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) approach which is independent of age and type of amblyopia. Furthermore, it has been shown recently that therapy promotes binocular vision by strengthening stereopsis and reducing suppression.
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.
Aim of the work:
To compare the gold standard occlusion therapy alone with dichoptic therapy
Patients and Methods:
Design:
The study will be a prospective experimental controlled study.
Patients of the study:
From the vicinity of the ophthalmology outpatient clinic of Ain Shams University Hospital, 100 patients of both sexes with amblyopia will be enrolled to this study. Informed consents will be obtained from adult patients and children's parents.
Patients will be assigned randomly into two groups:
Group A: 50 patients will receive the gold standard occlusion therapy
Group B: 50 patients will receive dichoptic treatment in the form of playing a video game (Lazy Eye Blocks ®) while wearing a red/green goggle.
Each group will be subdivided according to age:
- From 4 to 7 years.
- From above 7 to 12 years.
- From above 12 to 30 years.
Hours of occlusion will be classified according to the degree of amblyopia:
- Mild to moderate amblyopia (Best corrected visual acuity (BCVA)< 0.2): 2-4 hours occlusion
- Severe (BCVA> 0.2): 4-6 hours occlusion
Hours of dichoptic treatment in group B will be classified according to the degree of amblyopia:
- Mild to moderate amblyopia (BCVA< 0.2): 2-4 hours of treatment
- Severe (BCVA> 0.2): 4-6 hours of treatment
Methods
All patients will undergo the following:
- Full medical and ophthalmic history
- Examination:
- External Appearance:
Anomalous Head Position, globes (e.g., proptosis), lids (e.g. ptosis).
- Refraction:
With and without cyclopegia
- Visual acuity:
With and without correction using Snellen acuity chart and preferential looking test for non-verbal patients.
- Motility:
Ductions and versions (9 positions of gaze) E) Angle of deviation if any
- Fixation :
Fixation behavior (fixation preference) will be tested via base down 10 prism diopter fixation preference test.
- Quantitative Binocular vision assessment H) Anterior segment examination. I) Posterior segment examination using indirect ophthalmoscopy with a 20 diopter lens through a dilated pupil.
All patients in Group A will receive the gold standard occlusion therapy. All patients in Group B will receive dichoptic treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: eye patch50 patients will receive the gold standard occlusion therapy |
| Group B | Experimental | Device: dichoptic treatment50 patients will receive dichoptic treatment in the form of playing a video game (Lazy Eye Blocks ®) while wearing a red/green goggle. |
Who may qualify
- Ages
- 4 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Any degree of amblyopia
- Orthotropia in primary position.
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| eye patchOccluding the better seeing eye for a given number of hours daily | Device | Group A |
| dichoptic treatmentdichoptic treatment in the form of playing a video game (Lazy Eye Blocks ®) while wearing a red/green goggle. | Device | Group B |
Primary outcome
visual acuity
Time frame: 6 months
Best corrected visual acuity in the amblyopic eye
2 secondary outcomes
Compliance
Time frame: 6 months
crowding ratio
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
- Background: PubMed 25624680Aldebasi 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.
- Background: PubMed 9442792Attebo 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.
- Background: PubMed 23201436Birch 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.
- Background: PubMed 23397039Ding 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.
- Background: PubMed 24417338Ding 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.
- Background: PubMed 16531452Dixon-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.
- Background: PubMed 24742059Fu 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.
- Background: PubMed 23865603Ganekal 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.
- Background: PubMed 16540572He 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.
- Background: PubMed 25131694Hess 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.
- Background: PubMed 21870914Hess RF, Mansouri B, Thompson B. Restoration of binocular vision in amblyopia. Strabismus. 2011 Sep;19(3):110-8. doi: 10.3109/09273972.2011.600418.
- Background: PubMed 19250947Levi 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.
- Individual participant dataSharing planned: No
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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.
Hazem H Nouh, MD study chair
Ophthalmology department, faculty of medicine, Ain Shams University
Mohammad A Rashad, MD study chair
Ophthalmology department, faculty of medicine, Ain Shams University
Walid M El-Zawahry, MD study director
Ophthalmology department, faculty of medicine, Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eye patch and dichoptic treatment in people with Amblyopia, run by Ain Shams University at 1 site in Egypt.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 29 Nov 2022. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
visual acuity (time frame: 6 months). 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 NCT03255707, which also lists 29 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 29 Nov 2022.