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IRCT20211004052668N1 IRCT 2021-11-08 Mashhad University of Medical Sciences Evaluation of the effect of eye exercises with the device in the clinic as well as active vision therapy at home using a computer game that enhances vision simultaneously with two eyes and special glasses at home in improving the intermittent deviation of the eye outwards Evaluation of orthoptics thraputic effects using Major Amblyoscope (office-based therapy) as well as active vision therapy using Enhancement of binocular vision software and red-green glasses (home-based therapy) to improve controlling of intermittent exotropia 2021-06-26 anticipated 60 Complete https://irct.ir/trial/59178 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple individual randomization will be done using a random number table and the website WWW.Randomization.com. Random concealment will be done using packets in the package in which the envelopes are prepared by a member of the research team and the random numbers extracted from WWW.Randomization.com are prepared and printed and They are placed inside the envelope and will be closed in the envelopes and its contents will not be visible from the outside; Then, first the purpose of the study will be explained to the person who has the inclusion criteria and the person will sign the informed consent form and take an envelope and then open it and based on the contents of the envelope in the intervention or control group will enter, Blinding description: Outcome assessor means that the person who visits the patient and evaluates and records the consequences is not aware of how the patients are grouped. In other words, the outcome assessor of the patient who visits and evaluates the outcome is not aware that the patient is Comments are in the control group or in the intervention group. 3 Intermittent exotropia. Intervention 1: Intervention group: Anti suppresion and fusion therapy exercises are performed by major amblyoscope (in the presence of the clinic) and software for enhancing binocular vision and red-green glasses (as a practice at home) at the same time.The treatment is performed using Hagg Streit 2003 model major amblyoscope with the following program. In this way, a total of 22 sessions per patient and two sessions per week for twenty minutes by an experienced orthopthist. Each session will take between 20-30 minutes, depending on the patient. In the next three months of follow-up, patients will not receive special treatment. (Except for the necessary corrective glasses) and child playing computer games using filter glasses to stimulate both eyes at the same time at home that Patients (with the help of their parents) are asked to take 30 minutes twice a day (one hour a day) for 5 days a week for 4 weeks and then two days a week for 8 weeks (36 hours in total). The child should use computer games for three months. Intervention 2: The control group is patients undergoing more common anti suppresion therapy with patch therapy. The duration of patch therapy in these patients will be 1 to 2 hours per day, depending on the doctor's opinion (regarding the predominant eye and the division of closing hours between the two eyes alternately). This treatment is done for 5 months and no treatment is done in the sixth month. (Except for the necessary corrective glasses). Yes - There is a plan to make this available What will be shared: Individual Participant Data Set (IPD): all collected deidentified IPD could be shared. When: Starting 6 months after publication To whom: People working in academic institutions Conditions: No further criteria. Where to obtain: Mohammad Etezad Razavi: Khatam al-Anbia Eye Hospital, Aboutaleb Intersection, Mashhad, Iran etezadm@mums.ac.ir , 00989155199624 How to obtain: With a reasonable request, the data would be shared via email. Comments:
public Mohammad Etezad Razavi
Khatam Al-Anbia Eye Hospital, Aboutaleb Intersection
Mashhad Iran (Islamic Republic of) 9195965919 +98 51 3728 9911 etezadm@mums.ac.ir Mashhad University of Medical Sciences scientific Mohammad Etezad Razavi
Khatam Al-Anbia Eye Hospital, Aboutaleb Intersection
Mashhad Iran (Islamic Republic of) 9195965919 +98 51 3728 9911 etezadm@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Age group 5-18 years Exotropia less than 40 prisms Intermittent exotropia without significant vertical deviation or pattern فقدان آمبلیوپی فقدان اختلالات ساختمانی چشمها و عیوب انکساری بالا (میوپی بالای6 - و هیپروپی بالای 5/4 +) Obtaining the informed consent of the parents and the existence of cooperation in the child Having grades 2, 3 and 4 on the Mohney and Holms IXT Control Scale 5 years 18 years Both Lack of cooperation between parents and patients in the continuation of prescribed treatment H50.34 Intermittent alternating exotropia Treatment - Devices Treatment - Devices Intervention group: Anti suppresion and fusion therapy exercises are performed by major amblyoscope (in the presence of the clinic) and software for enhancing binocular vision and red-green glasses (as a practice at home) at the same time.The treatment is performed using Hagg Streit 2003 model major amblyoscope with the following program. In this way, a total of 22 sessions per patient and two sessions per week for twenty minutes by an experienced orthopthist. Each session will take between 20-30 minutes, depending on the patient. In the next three months of follow-up, patients will not receive special treatment. (Except for the necessary corrective glasses) and child playing computer games using filter glasses to stimulate both eyes at the same time at home that Patients (with the help of their parents) are asked to take 30 minutes twice a day (one hour a day) for 5 days a week for 4 weeks and then two days a week for 8 weeks (36 hours in total). The child should use computer games for three months. The control group is patients undergoing more common anti suppresion therapy with patch therapy. The duration of patch therapy in these patients will be 1 to 2 hours per day, depending on the doctor's opinion (regarding the predominant eye and the division of closing hours between the two eyes alternately). This treatment is done for 5 months and no treatment is done in the sixth month. (Except for the necessary corrective glasses) Intermittent exotropia control score. Timepoint: Before the intervention, one and a half months, three months and six months after starting treatment. Method of measurement: Based on the Mohney and Holmes Intermittent Exotropia Control Scale. Mashhad University of Medical Sciences Approved 2021-06-26 Ethics committee of Faculty of Medicine, Mashhad University of Medical Sciences No.37, Kosar Blvd, south Kosar between 7 & 9 Mashhad Razavi Khorasan Iran (Islamic Republic of)