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IRCT20230626058588N1 IRCT 2023-08-12 Iran University of Medical Sciences Investigating and comparing effect of low dose Atropine and minus lens therapy on intermittent exotropia. Investigating and comparing the effect of 0.05%Atropine with minus lens therapy method on angle and control of deviation in children with intermittent exotropia. 2023-07-06 anticipated 42 Complete https://irct.ir/trial/70963 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method is done in a simple way with individual units and computer software is used in this randomization. The sequence of randomization is given according to a table in the text of the proposal. To assign labels A and B to the intervention group of low-dose atropine and treatment with negative glasses, a coin toss lottery was used, and group B was determined as the intervention group (use of drops) and group A was determined as the intervention group of using glasses. 3 Intermittent exotropia. Intervention 1: Intervention group: Atropine 0.05% is an anticholinergic drug and the first intervention. In order to process this drop, we dilute 0.5% atropine made by Sina Daru Company 10 times with artificial tears. In fact, 1 ml of this drop is combined with 10 ml of artificial tear drops in a special container and given to patients. Parents are asked to put one drop of 0.05% atropine in each eye every day in the afternoon and within a certain time. Parents are taught how to put drops in each eye. Intervention 2: Intervention group: In the treatment with glasses, it will be prescribed based on the lowest power of the negative lens that will lead to the control and reduction of the angle of the deviation. First, the amount of negative lens power equal to 0.5 diopters is placed in front of the eyes, and if the deviation is still not in the controlled state, the amount of negative lens power is increased with steps of 0.25 diopters until the deviation is controlled. The value of the obtained number is added with the amount of spherical refractive error calculated from cyclorefraction and the final lens power is prescribed. If it is observed in the follow-up sessions that the deviation is not properly controlled, the power of the negative lens is increased. Yes - There is a plan to make this available What will be shared: The data of the participating in the study can be shared after de-identifying the people, which is provided to the requester through a SPSS file. When: The access period starts 6 months after the results are published. To whom: It will be available only to researchers working in academic and scientific institutions. Conditions: Only in order to check the correctness of the data and analyze them, they can be approved by researchers or scientific institutions. Where to obtain: Farzaneh Dehghanian Nasrabadi, Mobile number: 0098 9133609451, Gmail: Fdehghanian1991@gmail.com How to obtain: After sending an e-mail by a researcher or a person from a scientific and university institution to the mentioned e-mail address and after its verification by Mrs. Dehghanian, these data can be obtained. Comments:
public Farzaneh Dehghanian Nasrabadi
Rehabilitation school of Iran University of Medical Sciences, Madadkaran St, Madar square, Mirdamad Ave
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2222 7124 Fdehghanian1991@gmail.com Iran University of Medical Sciences scientific Farzaneh Dehghanian Nasrabadi
Rehabilitation school of Iran University of Medical Sciences, Madadkaran St, Madar square, Mirdamad Ave
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2222 7124 Fdehghanian1991@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Full term children with intermittent exotropia. 2 years 8 years Both Unilateral or bilateral amblyopia history of epilepsy or seizures and asthma history of drug sensitivity history of strabismus surgery presence of vertical deviation more than 5 prisms unwillingness to continue this study H50.34 Intermittent alternating exotropia Treatment - Drugs Treatment - Other Intervention group: Atropine 0.05% is an anticholinergic drug and the first intervention. In order to process this drop, we dilute 0.5% atropine made by Sina Daru Company 10 times with artificial tears. In fact, 1 ml of this drop is combined with 10 ml of artificial tear drops in a special container and given to patients. Parents are asked to put one drop of 0.05% atropine in each eye every day in the afternoon and within a certain time. Parents are taught how to put drops in each eye. Intervention group: In the treatment with glasses, it will be prescribed based on the lowest power of the negative lens that will lead to the control and reduction of the angle of the deviation. First, the amount of negative lens power equal to 0.5 diopters is placed in front of the eyes, and if the deviation is still not in the controlled state, the amount of negative lens power is increased with steps of 0.25 diopters until the deviation is controlled. The value of the obtained number is added with the amount of spherical refractive error calculated from cyclorefraction and the final lens power is prescribed. If it is observed in the follow-up sessions that the deviation is not properly controlled, the power of the negative lens is increased. Angle of deviation, control of deviation. Timepoint: Before, one month and 3 months after intervention. Method of measurement: Angle of deviation: prism bar and cover test. Control of deviation: 3 and 6 scale criteria. Stereopsis. Timepoint: Before, one month and 3 months after intervention. Method of measurement: Stereopsis: Titmus. Suppression. Timepoint: Before, one month and 3 months after intervention. Method of measurement: 4 dots Worth test. Accommodation response. Timepoint: Before, one month and 3 months after intervention. Method of measurement: MEM dynamic retinoscopy. Iran University of Medical Sciences Approved 2023-05-27 Ethics committee of Iran University of Medical Sciences Hemat Highway next to Milad Tower Tehran Tehran Iran (Islamic Republic of)