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IRCT20240617062160N1 IRCT 2024-06-29 Shahid Beheshti University of Medical Sciences The effectiveness of fluoxetine on the treatment of adaptive spasm caused by anxiety Investigating the effect of fluoxetine on the treatment of accomodative spasm caused by anxiety 2024-08-01 anticipated 68 Complete https://irct.ir/trial/77488 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The block randomization method is used to assign the participants to two groups of thirty-four people. In the block randomization method, we create blocks of four and randomly select a block of four for each four people. The block modes of four are as follows: AABB, ABAB, ABBA, BAAB, BABA, BBAA. We randomly choose one of the six quadruple block modes. For example, if the first mode is AABB, the first and second players are in group A, and the third and fourth players are in group B. We put them in the envelope and number each one from 1 to 64, Blinding description: The main researcher is blinded to the selection and randomization of participants, and assigning groups will be done by another colleague. Treatment for the intervention group will be done on even days of the week and treatment for the control group will be done on odd days of the week, so the participants will be blinded to their treatment and group assignment. Data collection and analysis after the completion of the interventions will be done by another colleague who is blind to group assignment. N/A Accommodative spasm. Intervention 1: Intervention group: Patients with anxiety are treated with fluoxetine 20 for 5 weeks, and in the fifth week, patients are treated with vision therapy under the supervision of an optometrist for three months. Intervention 2: Patients who suffer from anxiety and are only treated with fluoxetine 20 for 5 weeks. Intervention 3: Intervention group: Patients who do not suffer from anxiety and are given a suitable placebo similar to fluoxetine for 5 weeks, and in the fifth week, patients are treated with vision therapy under the supervision of an optometrist for three months. Intervention 4: Control group: Patients who do not suffer from anxiety and are given a suitable placebo similar to fluoxetine for 5 weeks. 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 After data collection, If the consent of the participants is obtained, the data file of the participants can be published
public Mehrdad Sadeghi
Shahid Beheshti University of Medical Sciences, School of Rehabilitation, Damavand St., Emam Hossein Sq
Tehran Iran (Islamic Republic of) 1616913111 +98 21 7756 1721 sadeghiop88@yahoo.com Shahid Beheshti University of Medical Sciences scientific Mehrdad Sadeghi
Shahid Beheshti University of Medical Sciences, School of Rehabilitation, Damavand St., Emam Hossein Sq
Tehran Iran (Islamic Republic of) 1616913111 +98 21 7756 1721 sadeghiop88@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Having eye spasms with symptoms Bilateral accommodative spasm (there should be conditions in both eyes and it should not be unilateral) No history of underlying diseases Absence of strabismus 15 years 30 years Both Uncorrected hyperopia Having systemic diseases Having pathological anxiety Having eye diseases such as keratoconus, cataract, uveitis, retinal retinopathy, and all diseases that affect the quality of vision and visual system of the patient. H52.5 Disorders of accommodation Treatment - Other Treatment - Drugs Treatment - Other Placebo Intervention group: Patients with anxiety are treated with fluoxetine 20 for 5 weeks, and in the fifth week, patients are treated with vision therapy under the supervision of an optometrist for three months. Patients who suffer from anxiety and are only treated with fluoxetine 20 for 5 weeks Intervention group: Patients who do not suffer from anxiety and are given a suitable placebo similar to fluoxetine for 5 weeks, and in the fifth week, patients are treated with vision therapy under the supervision of an optometrist for three months. Control group: Patients who do not suffer from anxiety and are given a suitable placebo similar to fluoxetine for 5 weeks Dry refractive error. Timepoint: At the beginning of the study (before the start of the intervention), 5 weeks after the start of fluoxetine, and 3 months after the start of vision therapy. Method of measurement: Autorefractometer device. Cyclo refractive error. Timepoint: At the beginning of the study (before the start of the intervention), 5 weeks after the start of fluoxetine, and 3 months after the start of vision therapy. Method of measurement: Autorefractometer device. Best corrected visual acuity. Timepoint: At the beginning of the study (before the start of the intervention), 5 weeks after the start of fluoxetine, and 3 months after the start of vision therapy. Method of measurement: Glasses or contact lenses. Amplitude of accommodation. Timepoint: En At the beginning of the study (before the start of the intervention), 5 weeks after the start of fluoxetine, and 3 months after the start of vision therapy. Method of measurement: Dynamic retinoscopy. Facility of accommodation. Timepoint: En At the beginning of the study (before the start of the intervention), 5 weeks after the start of fluoxetine, and 3 months after the start of vision therapy. Method of measurement: Dynamic retinoscopy. Shahid Beheshti University of Medical Sciences Approved 2024-05-26 Ethics committee of Shahid Beheshti University of Medical Science Arabi Ave., Daneshjoo Blvd., Velenjak Tehran Tehran Iran (Islamic Republic of)