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IRCT20180217038768N1 IRCT 2019-04-22 Mashhad University of Medical Sciences Effect of computer game in treatment of amblyopia The therapeutic role of computer Interactive Binocular game in cases of mild to moderate refractive amblyopia 2019-05-31 anticipated 44 Complete https://irct.ir/trial/38154 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Before starting a study in a 3-month period, an amblyopia treatment pilot game will be performed in eligible patients, Randomization description: 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. 3 anisometropic amblyopia. Intervention 1: 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. Intervention 2: 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). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Jaber Mohseni
Khatam Al Anbia Hospital, Gharani Blvd
Mashhad Iran (Islamic Republic of) 9195965919 +98 51 3728 1401 mohsenij951@mums.ac.ir Mashhad University of Medical Sciences scientific MD Mohammad Etezad Razavi
Gharani Blvd
Mashhad Iran (Islamic Republic of) 9195965919 +98 51 3728 1400 etezadm@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) 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. 4 years 12 years Both 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. H52.31 Anisometropia Treatment - Devices Rehabilitation 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. 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). Best corrected visual acuity. Timepoint: 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. Method of measurement: Measuring the Best corrected visual acuity by early treatment diabetic retinopathy study chart, according to the crowded protocol. Stereopsis. Timepoint: 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. Method of measurement: Measuring the stereopsis by Randot stereo test. Fusion. Timepoint: 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. Method of measurement: Measuring the fusion by Worth four dot test. Phoria and tropia. Timepoint: 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. Method of measurement: Measuring of phoria and tropia by cover uncover test, alternate prism and cover test, hirschburg, krimsky. Mashhad University of Medical Sciences Approved 2018-02-28 Ethics committee of Mashhad University of Medical Sciences Khatam Al Anbia Hospital, Gharani street Mashhad Razavi Khorasan Iran (Islamic Republic of)