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The therapeutic role of computer Interactive Binocular game in cases of mild to moderate refractive amblyopia

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History
# Registration date Revision Id
3 2021-08-21, 1400/05/30 195419
2 2020-07-15, 1399/04/25 143316
1 2019-04-22, 1398/02/02 87341
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  • Protocol summary

    Two arms parallel group randomized Clinical trial design of 44 patients, will enroll between March 2019 and September 2020.
    Two arms parallel group randomized Clinical trial design of 44 patients.
    کارازمایی بالینی دارای گروه کنترل, با گروههای موازی,تصادفی شده با روش پاکت نامه با حجم نمونه 44 نفر که در تاریخ اسفند 97 تا شهریور 99 مراجعه کرده اند
    کارازمایی بالینی دارای گروه کنترل, با گروههای موازی,تصادفی شده با روش پاکت نامه با حجم نمونه 44 نفر

  • General information

    2019-03-20, 1397/12/29
    2019-05-31, 1398/03/10
    2020-09-20, 1399/06/30
    2021-03-18, 1399/12/28
    empty
    lack of access to anaglyph glasses and delay in starting the study
    empty
    عدم دسترسی به عینکهای اناگلیف و تأخیر در شروع مطالعه

  • Recruitment centers

    #1
    Name of recruitment center - English: Khatam al anbia hospital
    Name of recruitment center - Persian: بیمارستان خاتم الانبیا
    Full name of responsible person - English: MD Mohammad Etezad razavi
    Full name of responsible person - Persian: دکتر محمد اعتضاد رضوی
    Street address - English: Gharani
    Street address - Persian: قرنی
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9195965919
    Phone: +98 51 3827 1400
    Fax: +98 51 3728 5293
    Email: etezadm@mums.ac.ir
    Web page address:
    Name of recruitment center - English: Khatam Al Anbia Hospital
    Name of recruitment center - Persian: بیمارستان خاتم الانبیا
    Full name of responsible person - English: MD Mohammad Etezad Razavi
    Full name of responsible person - Persian: دکتر محمد اعتضاد رضوی
    Street address - English: Gharani
    Street address - Persian: قرنی
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9195965919
    Phone: +98 51 3827 1400
    Fax: +98 51 3728 5293
    Email: etezadm@mums.ac.ir
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: MD Mohammad Etezad razavi
    Full name of responsible person - Persian: دکتر محمد اعتضاد رضوی
    Street address - English: Gharani
    Street address - Persian: قرنی
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9195965919
    Phone: +98 51 4728 1402
    Fax: +98 51 3728 5293
    Email: etezadm@mums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Pharmd Mohsen Tafaghodi
    Full name of responsible person - Persian: دکتر محسن تفقدی
    Street address - English: School of Pharmacy, Nanotechnology Research Center, Mashhad University of Medical Sciences
    Street address - Persian: دانشگاه علوم پزشکی مشهد, مرکز تحقیقات نانوتکنولوژی, دانشکده داروسازی
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 91775-1365
    Phone: +98 51 3882 3255
    Fax: +98 51 3882 3251
    Email: tafaghodim@mums.ac.ir
    Web page address:

Protocol summary

Study aim
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
Design
Two arms parallel group randomized Clinical trial design of 44 patients.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
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).
Main outcome variables
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

Reason for update
lack of access to anaglyph glasses and delay in starting the study
Acronym
IRCT registration information
IRCT registration number: IRCT20180217038768N1
Registration date: 2019-04-22, 1398/02/02
Registration timing: prospective

Last update: 2020-07-16, 1399/04/26
Update count: 2
Registration date
2019-04-22, 1398/02/02
Registrant information
Name
Jaber Mohseni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5540 0011
Email address
Mohsenij951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-31, 1398/03/10
Expected recruitment end date
2021-03-18, 1399/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The therapeutic role of computer Interactive Binocular game in cases of mild to moderate refractive amblyopia
Public title
Effect of computer game in treatment of amblyopia
Purpose
Treatment
Inclusion/Exclusion criteria
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.
Age
From 4 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Before starting a study in a 3-month period, an amblyopia treatment pilot game will be performed in eligible patients.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Khatam Al Anbia Hospital, Gharani street
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Approval date
2018-02-28, 1396/12/09
Ethics committee reference number
IR.MUMS.fm.REC.1396.783

Health conditions studied

1

Description of health condition studied
anisometropic amblyopia
ICD-10 code
H52.31
ICD-10 code description
Anisometropia

Primary outcomes

1

Description
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

Secondary outcomes

1

Description
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

2

Description
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

3

Description
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

Intervention groups

1

Description
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.
Category
Treatment - Devices

2

Description
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).
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Khatam Al Anbia Hospital
Full name of responsible person
MD Mohammad Etezad Razavi
Street address
Gharani
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Phone
+98 51 3827 1400
Fax
+98 51 3728 5293
Email
etezadm@mums.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Pharmd Mohsen Tafaghodi
Street address
School of Pharmacy, Nanotechnology Research Center, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
91775-1365
Phone
+98 51 3882 3255
Fax
+98 51 3882 3251
Email
tafaghodim@mums.ac.ir
Grant name
Mashhad university research unit
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Jaber Mohseni
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Khatam Al Anbia Hospital, Gharani Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Phone
+98 51 3728 1401
Fax
Email
mohsenij951@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
MD Mohammad Etezad Razavi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Gharani Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Phone
+98 51 3728 1400
Email
etezadm@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Jaber Mohseni
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Khatam al-anbia hospital٬ Gharanei Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Phone
+98 51 3728 1401
Fax
Email
mohsenij951@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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