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IRCT20230823059229N1 IRCT 2024-02-28 Shahid Beheshti University of Medical Sciences Investigation the Effect of Active Vision Therapy Using Vision Therapy System 4 (VTS4) in Bilateral Refractive Amblyopia 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 2025-03-05 anticipated 40 Complete https://irct.ir/trial/74330 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. N/A amblyopia, lazy eye. Intervention 1: "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. Intervention 2: "Control group:" 1-2 hours patching each eye every day and placebo training. Yes - There is a plan to make this available What will be shared: Information about the primary outcome measure can be shared. When: starting 6 months after publication To whom: available for people working in academic institutions and people working in businesses can apply to receive it. Conditions: without limitation Where to obtain: Saeedeh Hosseinmenni, researcher of the study: s.hoseiny2021@gmail .com How to obtain: Two months after application Comments:
public Saeedeh Hosseinmenni
Rehabilitation school of SBMU, Damavand St, Tehran
Tehran Iran (Islamic Republic of) 1616913111 +98 21 7756 1721 s.hoseiny2021@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Saeedeh Hoseinmenni
N 105., floor 1., Otana Flat, Maali Abad BVL, Shiraz
Shiraz Iran (Islamic Republic of) 7187711733 +98 71 3634 1939 s_hoseiny2008@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) 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) 5 years 13 years Both 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 H53.023 Refractive amblyopia, bilateral, Rehabilitation Rehabilitation "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 "Control group:" 1-2 hours patching each eye every day and placebo training 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. 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. Contrast sensitivity. Timepoint: before and after. Method of measurement: Freiburg contrast sensitivity test, made in Germany, designed by Michael Bach, 2011 version. Infacility of Accommodation. Timepoint: Before and after. Method of measurement: flipper lens and snellen near chart. Shahid Beheshti University of Medical Sciences Approved 2023-11-26 Ethics committee of Shahid Beheshti university of medical sciences floor. 13, flat A, he central headquarters of the Ministry of Health, Simayr Iran street, Shahrak Ghods, Tehran Tehran Tehran Iran (Islamic Republic of)