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IRCT20241003063251N1 IRCT 2024-12-09 Shahid Beheshti University of Medical Sciences The effect of atropine drops on the treatment of lazy eye in children Effect of Combined Atropine and Patch Therapies for Amblyopia treatment in Children aged 3-17 years old 2024-12-05 anticipated 100 Complete https://irct.ir/trial/79629 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Randomization description: This study uses a simple randomization approach, dividing patients into two groups.one group(A) receives patch therapy alone, while the other group(B) receives patch therapy along with one drop pf 1% atropine, administered once a day for five days a week (excluding Thursday and Fridays) for 3 months and evaluation is done every three months. if the amblyopia improves and the BCVA of both eyes is equal, atropine is stopped, and patch therapy also gradually decreases and stops. if there is no response after 6 months, the treatment with atropine is stopped, and in patients who have a partial response to the treatment, the treatment with drops continues. 0 (exploratory trials) Amblyopia. Intervention 1: Treatment group(A): treatment with patching alone. Intervention 2: Treatment group(B): treatment with patching and atropine drop. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Mohadeseh Feizi
Shahid Beheshti University of Medical Sciences, Yemen Street, Velenjak, Tehran
Tehran Iran (Islamic Republic of) 1916511625 +98 21 23871 mohadeseh_feizi@yahoo.com Shahid Beheshti University of Medical Sciences scientific Maryam Oraee Yazdani
Shahid Beheshti University of Medical sciences, Yemen Street, Velenjak, Tehran
Tehran Iran (Islamic Republic of) 1988873554 +98 21 2243 8023 maryam_o_yazdani@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Children from 3 to 17 years of age referred to the strabismus clinic of Torfeh training center Unilateral amblyopia and refractory to treatment due to strabismus or anisometropia or depreciative or combined Failure to respond to previous patch therapy treatment means failure to improve BCVA at least two lines according to the Snellen chart after patch therapy for at least 6 months. 3 years 17 years Both Children outside the age range of 3 to 17 years old Non refractory amblyopia H-52 Disorders of refraction and accommodation Treatment - Drugs Treatment - Other Treatment group(A): treatment with patching alone Treatment group(B): treatment with patching and atropine drop Corrected vision before treatment and 6 months after treatment. Timepoint: Before starting, 3 months later, 6 months after treatment. Method of measurement: logmar. No Approved 2024-07-31 Ethics committee of Shahid beheshti university of medical science Daneshjou Blvd., Velenjak, Shahid beheshti university of medical science Tehran Tehran Iran (Islamic Republic of)