Investigation the Effect of Active Vision Therapy on visual skills using Vision Therapy System 4 (VTS4) in children with Bilateral Refractive Amblyopia ages 5-13
General objectives:
Determining the effect of active vision therapy(AVT) using vision therapy system version 4 in children with bilateral refractive amblyopia(BRA)
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, on 40 patients. (Block randomization )
Settings and conduct
Selection of bilateral refractive amblyopia patient, aged 5-13 years, as available in Postachi clinic
They will be referred to the Soroosh optometry center for full examination( VA, SA, CS, AI)
Program for treatment group will be three 30-minute sessions AVT per week with patching.
The control group will have patch and placebo vision therapy sessions.
Difference consideration: at least one line improvement in VA.
patients and optometrists who check before and after test will be blinded.
Participants/Inclusion and exclusion criteria
inclusion criteria:
age between 5 - 13 years
Astigmatism or hyperopia in each eye or a mix hyperopia-astigmatism
Maximom VA 20/40 and Minimum VA 20/100 in each eye
exclusion criteria:
weak follow-up for treatment.
The existence of pathological and structural problems of the eyes
History of eye surgeries
strabismus, microtropia or eccentric fixation
Intervention groups
AVT for the treatment group and patching for control group.
for Treatment group active vision exercises and patching, for control group, patching and placebo training
Main outcome variables
Improvement of visual acuity, stereacuity, contrast sensitivity and facility of accommodation.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230823059229N1
Registration date:2024-02-28, 1402/12/09
Registration timing:prospective
Last update:2024-02-28, 1402/12/09
Update count:0
Registration date
2024-02-28, 1402/12/09
Registrant information
Name
Saeedeh Hosseinmenni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7756 1721
Email address
s.hoseiny2021@sbmu.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-03-05, 1403/12/15
Expected recruitment end date
2025-11-21, 1404/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the Effect of Active Vision Therapy on visual skills using Vision Therapy System 4 (VTS4) in children with Bilateral Refractive Amblyopia ages 5-13
Public title
Investigation the Effect of Active Vision Therapy Using Vision Therapy System 4 (VTS4) in Bilateral Refractive Amblyopia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Full patient consent to participate in the study
The minimum age is 5 and the maximum is 13 years
Bilateral refractive amblyopes
Astigmatism more than 1.5 diopters and hyperopia more than 3.00 diopters in each eye or a mix hyperopia-stigmatism
Maximum vision 20/40 and minimum vision 20/100 in each eye (moderate amblyopia)
Exclusion criteria:
Children who do not cooperate to perform the tests
Children who experience diplopia or nausea while using liquid crystal glasses
The presence of uncompensated phoria
Children who do not have the necessary follow-up for treatment.
The existence of pathological and structural problems of the eye
History of eye surgeries
The presence of nystagmus
strabismus, microtropia or eccentric fixation
Age
From 5 years old to 13 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
patient divide in two control and active treatment groups. Block Randomization is used for this. Blocks of couple of four are created in which, randomly, half of the people in each group are placed in one block and the others in the other group. Using blocks of couple of four, we will place 40 people in two control and treatment groups. First, we determine all the four states in which group.
We consider the treatment group as A and the control group as B.
1-AABB
2-ABBA
3-ABAB
4-BBAA
5-BABA
6-BAAB
Then, we will randomly select 8 blocks of four and write their combination one after the other, in fact, we will sample 8 times from this 6-member society, that is, a random number between 1 and 6 will be selected 8 times. In this way, the type of treatment will be determined for 40 patients.
Blinding (investigator's opinion)
Double blinded
Blinding description
It will be made in a double-blind manner. In order for the researcher not to know whether the examinee is in the active or inactive vision therapy group, vision therapy will be performed by one person and the main researcher will perform other examinations. In order to blind the participants , we will also consider sessions to perform placebo vision therapy exercises in the office for the patching group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti university of medical sciences
Street address
floor. 13, flat A, he central headquarters of the Ministry of Health, Simayr Iran street, Shahrak Ghods, Tehran
City
Tehran
Province
Tehran
Postal code
1467664961
Approval date
2023-11-26, 1402/09/05
Ethics committee reference number
IR.SBMU.RETECH.REC.1402.513
Health conditions studied
1
Description of health condition studied
amblyopia, lazy eye
ICD-10 code
H53.023
ICD-10 code description
Refractive amblyopia, bilateral,
Primary outcomes
1
Description
visual acuity
Timepoint
before and after
Method of measurement
snellen vision chart LCD chart vision (model, HDC-9000N/PF, made in South Korea) Howitz company
2
Description
stereoacuity
Timepoint
before and after
Method of measurement
Randot &; Vectogram Registered trade marks of Stereo Optical Co., Inc and Stereo Fly Stereotest of Stereo Optical Company Inc
3
Description
contrast sensitivity
Timepoint
before and after
Method of measurement
Freiburg contrast sensitivity test, made in Germany, designed by Michael Bach, 2011 version
4
Description
Infacility of Accommodation
Timepoint
Before and after
Method of measurement
flipper lens and snellen near chart
Secondary outcomes
empty
Intervention groups
1
Description
"Intervention group:" Patching and Vision therapy exercises in three sessions of 30 minutes a week with the Vision Therapy System version 4 (an American software (HTS Inc., Gold Canyon, AZ, USA))، consisting of a 50-inch monitor, a case, a gamepad and a pair of liquid crystal glasses and patching eye
Category
Rehabilitation
2
Description
"Control group:" 1-2 hours patching each eye every day and placebo training
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Poostchi clinic
Full name of responsible person
Dr Mohammadreza Talennejad
Street address
Karimkhan Zand Blvd., Shiraz
City
Shiraz
Province
Fars
Postal code
7184997446
Phone
+98 71 3233 0073
Fax
+98 71 3235 2400
Email
poostchi@sums.ac.ir
Web page address
https://poostchi.sums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Saeed Rahmani
Street address
In front of Bo Ali Hospital, Damavand Street, Imam Hossein Square, Tehran
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7715 9535
Email
rehab.sbmu@gmail.com
Web page address
https://rehab.sbmu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saeedeh Hosseinmenni
Position
PHd candidate
Latest degree
Master
Other areas of specialty/work
Optometry
Street address
Rehabilitation school of SBMU, Damavand St, Tehran
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7756 1721
Fax
Email
s.hoseiny2021@sbmu.ac.ir
Web page address
https://rehab.sbmu.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saeedeh Hoseinmenni
Position
Student
Latest degree
Master
Other areas of specialty/work
Optometry
Street address
N 105., floor 1., Otana Flat, Maali Abad BVL, Shiraz
City
Shiraz
Province
Fars
Postal code
7187711733
Phone
+98 71 3634 1939
Email
s_hoseiny2008@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saeedeh Hosseinmenni
Position
PHd Candidate
Latest degree
Master
Other areas of specialty/work
Optometry
Street address
Rehabilitation School of SBMU, Damavand St, Tehran
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7756 1721
Fax
Email
s.hoseiny2021@sbmu.ac.ir
Web page address
https://rehab.sbmu.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Information about the primary outcome measure can be shared.
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
available for people working in academic institutions and people working in businesses can apply to receive it.
Under which criteria data/document could be used
without limitation
From where data/document is obtainable
Saeedeh Hosseinmenni, researcher of the study:
s.hoseiny2021@gmail .com
What processes are involved for a request to access data/document