Protocol summary
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Study aim
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A comparative study and evaluation of the effect of computer game designed with two-eye vision stimulation separation for the treatment of patients with mild to moderate amblyopia and compare it with traditional patch therapy
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Design
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Two arms parallel group randomized Clinical trial design of 44 patients.
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Settings and conduct
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Children with a definite anisometropic amblyiopia are randomly divided into two groups A and B, and for one group ,patch therapy and for other group, anaglyphic glasses with game are used. The two groups will be evaluated 5 times in three months. Finally, two methods of treatment are compared with the standard software.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Children aged 4 to 12 years with mild-to-moderate anisometropic amblyopia who had not previously been treated with amblyopia and whose parents were willing to enter the study.
Exclusion criteria:
Patients with amblyopia with other causes (non-refractive), neurological motor disorder and brain lesions that do not have the ability to work with computers and do not play.
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Intervention groups
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In the case group, treatment of amblyopia is performed with anaglyphic glasses with red and green glasses placed in front of the lazy eye and healthy eyes, along with a game designed for a 3-month period.
In the control group, the amblyiopia is treated with patch therapy according to conventional procedures and lasts for 3 months (according to the abmlyiopia treatment study protocol).
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Main outcome variables
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In two groups, the examinations consist of best corrected visual acuity, depth of vision (streopsis) and fusion, testing at pre-treatment intervals, two weeks after the start of treatment, one, two, and three months after the start of treatment, five times in total.
General information
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Reason for update
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lack of access to anaglyph glasses and delay in starting the study
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180217038768N1
Registration date:
2019-04-22, 1398/02/02
Registration timing:
prospective
Last update:
2021-08-27, 1400/06/05
Update count:
2
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Registration date
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2019-04-22, 1398/02/02
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-05-31, 1398/03/10
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Expected recruitment end date
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2021-09-30, 1400/07/08
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The therapeutic role of computer Interactive Binocular game in cases of mild to moderate refractive amblyopia
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Public title
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Effect of computer game in treatment of amblyopia
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Children aged 4 to 12 years old
Children with anisometropic amblyopia (amblyopia in the presence of a spherical equivalent ≥0.50 diopter between the two eyes or the difference in stigmatism in any meridian ≥1.50 diopter) with mild to moderate severity
Children who have not previously been treated with ambiopia.
Children whose parents have the consent to enter the study.
Exclusion criteria:
Patients with amblyopia with other causes (non-refractive)
Patients with motor neurological disorder and brain lesions that do not have the ability to work with the computer and do not play.
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Age
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From 4 years old to 12 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
44
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Unfortunately, due to the nature of the intervention, the use of special glasses does not allow patients to blind. But the optometrist will be unaware of the patient grouping. Patients will be rendered using envelopes, and patients will fall into one of two groups, A or B, according to the accident. An individual who groups patients does not know the nature of Group A or B.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Before starting a study in a 3-month period, an amblyopia treatment pilot game will be performed in eligible patients.
Ethics committees
1
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Ethics committee
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Approval date
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2018-02-28, 1396/12/09
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Ethics committee reference number
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IR.MUMS.fm.REC.1396.783
Health conditions studied
1
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Description of health condition studied
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anisometropic amblyopia
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ICD-10 code
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H52.31
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ICD-10 code description
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Anisometropia
Primary outcomes
1
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Description
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Best corrected visual acuity
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Timepoint
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Measuring the Best corrected visual acuity at the beginning of the study (before the intervention), two weeks, one month, two months and three months after the intervention began.
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Method of measurement
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Measuring the Best corrected visual acuity by early treatment diabetic retinopathy study chart, according to the crowded protocol
Secondary outcomes
1
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Description
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Stereopsis
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Timepoint
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Measuring the stereopsis at the beginning of the study (before the intervention), two weeks, one month, two months and three months after the intervention began.
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Method of measurement
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Measuring the stereopsis by Randot stereo test
2
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Description
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fusion
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Timepoint
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Measuring the fusion at the beginning of the study (before the intervention), two weeks, one month, two months and three months after the intervention began.
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Method of measurement
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Measuring the fusion by Worth four dot test
3
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Description
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Phoria and tropia
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Timepoint
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Measuring phoria and tropia at the beginning of the study (before the intervention), two weeks, one month, two months and three months after the intervention began.
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Method of measurement
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Measuring of phoria and tropia by cover uncover test, alternate prism and cover test, hirschburg, krimsky
Intervention groups
1
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Description
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Intervention group: Based on the principle that the lazy eye should be exposed to more complex and moving images and static images for the stronger eyes, a computer game designed to enhance binocularity in another design is designed by the main executor. The images in this game are designed to be used with special glasses to filter out green and red images for strong and lazy eye respectively. Also, in order to stimulate the lazy eye, at each step, the speed of moving images increases and their contrast will change.The game will be installed on a tablet or mobile device, and with the red green glasses for this game, it can be seen with the separation of moving red and static green images (anaglyphics). In the intervention group, patients (with the help of their parents) are asked to take 30 minutes twice daily (once an hour) for 5 days a week for 4 weeks and then two days a week for 8 weeks (total 36 hours) for the child Use a computer game within three months. Children should wear anaglyphic glasses with their glasses when playing.
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Category
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Treatment - Devices
2
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Description
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Control group:In the control group, patch therapy is performed according to conventional procedures and continues for 3 months (according to the Ambliopia Treatment Study).
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Mashhad university research unit
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mashhad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available