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IRCT20240325061363N1 IRCT 2024-04-20 Yazd University of Medical Sciences the effect of pilocarpine 1% eye drop on the relative improvement of presbyopia the effect of pilocarpine 1% eye drop on the relative improvement of presbyopia 2024-04-06 anticipated 60 Complete https://irct.ir/trial/76206 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: After the patient consumes the drops, his uncorrected near visual acuity and uncorrected far visual acuity are measured again based on the times mentioned in the goals, and on the 30th day after examination with a slit lamp, the side effects of the drug are also measured, Randomization description: Patients will be divided into two groups A and B using a random table of numbers from 1 to 60 and each number will be randomly assigned to a group (A or B) and the corresponding drops will be prescribed for each group, Blinding description: In order for the study to be three-way blind, pilocarpine 1% drops and Tearlose artificial tears drops are prepared by the pharmacist of Shahid Sadouqi Hospital pharmacy (Mr. Dr. Fallah) in the same packaging with A or B stickers, and only he knows The type of drops A and B (researcher, patient and statistical consultant are not informed) and after collecting and announcing the results, the type of drops will be determined (announced) and the general statistical results will be reported based on the type of drops used by the patients. 3 presbyopia. Intervention 1: Intervention group: sterile eye drops Pilocarpine 1% (Sina darou company) every morning, one drop in each eye for one month. Intervention 2: Control group: sterile eye drops Tearlose (Sina darou company) every morning, one drop in each eye for one month. Yes - There is a plan to make this available What will be shared: Clinical study report When: After completing the study and printing the results To whom: Academic researchers Conditions: As a review of texts in other articles Where to obtain: responsible author How to obtain: Follow up via email of the responsible author Comments:
public Mohammad hosein Abutorabi zarchi
No. 11, South Rezvan Alley 2, Professor Hasabi Blvd., University Town
Yazd Iran (Islamic Republic of) ۸۹۱۶۱۱۶۷۸۸ +98 35 3820 0782 m.h.abootorabi222@gmail.com Yazd University of Medical Sciences scientific Mohammad hosein Abutorabi zarchi
No. 11, South Rezvan Alley 2, Professor Hasabi Blvd., University Town
Yazd Iran (Islamic Republic of) ۸۹۱۶۱۱۶۷۸۸ +98 35 3820 0782 m.h.abootorabi222@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) Patients aged 40-60 years Suffering from presbyopia Uncorrected near visual acuity: 20/40 to 20/100 40 years 60 years Both Eye diseases (including glaucoma, cataracts, amblyopia, high myopia, eye trauma, congenital pupil abnormalities, corneal opacity, intraocular surgeries) Severe sensitivity and side effects to eye drops Taking drugs that interact with pilocarpine H52.4 Presbyopia Treatment - Drugs Treatment - Drugs Intervention group: sterile eye drops Pilocarpine 1% (Sina darou company) every morning, one drop in each eye for one month Control group: sterile eye drops Tearlose (Sina darou company) every morning, one drop in each eye for one month Uncorrected near visual acuity and uncorrected distance visual acuity. Timepoint: Before the intervention, 20 minutes later, one hour and six hours later, as well as on the 14th and 30th days. Method of measurement: Snellen chart. Yazd University of Medical Sciences Approved 2024-03-13 Research Ethics Committee of school of medicine- Shahid Sadoughi University of Medical Sciences Vice President of Research and Technology of yazd Shahid Sadougi University of Medical Sciences, Imam Reza Research Educational Complex, Student Blvd., Imam Hossein Square, Yazd Yazd Yazd Iran (Islamic Republic of)