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IRCT20180205038617N1 IRCT 2018-04-09 Mashhad University of Medical Sciences Effect of prednisolon acetete drop on pupil dilation and ocular pain after cataract surgery Evaluation the effect of topical prednisolon acetate 1% on the pupillary diameter and ocular pain after uncomplicated cataract surgery in diabetic and non diabetic patients 2017-03-13 anticipated 80 Complete https://irct.ir/trial/29548 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: If non-diabetic patients have inclusion criteria, they will be divided in to 2 groups of A and B through simple random sampling and using envelopes. Also, diabetic patients that have inclusion criteria will be divided in to 2 groups of C and D through simple random sampling and using envelopes, Blinding description: Patients in control group were given placebo which its appearance was the same as the medication which was administered for intervention group. All participants, researcher, surgeons and outcome investigator were blind about the medication were used for each patient. 3 Effect of topical dipped prednisolone acetate 1% on pupil dilatation and pain after uncomplicated cataract surgery. Intervention 1: Intervention 1: Non-diabetic patients who recieve topical prednisone acetate 1% drop, every six hours, 24 hours before surgery. Patients are advised to shake the bottle before using. The administered drop is produced by Sinadaroo company. Intervention 2: Intervention group: Diabetic patients who receive topical prednisone acetate 1% every six hours, 24 hours before surgery. Patients are advised to shake the bottle before using. The administered drop is produced by Sinadaroo company. Intervention 3: Control group1: Non-Diabetic patients who receive preservative- free artificial tears every six hours, 24 hours before surgery. The administered drop is produced by Sinadaroo company. Intervention 4: Control group2: Diabetic patients who receive preservative- free artificial tears every six hours, 24 hours before surgery. The administered drop is produced by Sinadaroo company. Yes - There is a plan to make this available What will be shared: Total data of patients and research result are shareable after undetectabling of patient since 2019 When: From2019 To whom: Researchers of academic center only Conditions: Clinical and practical usage is okay Where to obtain: Email:Hoseinzadea1@mums.ac.ir Tel:00989122276382 How to obtain: Send an email to Hoseinzadeha1@mums.ac.ir Comments:
public Hoseinzadeh Abolfazl
No23,Besat ave.,Ahmadabad Blvd.
Mashhad Iran (Islamic Republic of) 9175934333 +98 51 3840 2924 Hoseinzadeha1@mums.ac.ir Mashhad University of Medical Sciences scientific Hoseinzadeh abolfazl
No23,Beesat Blvd,Ahmadabad Town
Mashhad Iran (Islamic Republic of) 9175934333 +98 51 3840 2924 Hoseinzadeha1@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) In non- diabetic group: Patients over 40 years old with cortical cataract, posterior subcapsular or grade 2 to 3 nuclear sclerosis that have indication of phacoemulsification surgery with general anesthesia In diabetic group: Patients over 40 years old with cortical cataract, posterior subcapsular or grade 2 to 3 nuclear sclerosis that have pseudoexfuliation or non proliferative diabetic retinopathy and have indication of phacoemulsification surgery with general anesthesia 40 years no limit Both History of previous intraocular surgery collagen vascular disease history of previous or current topical steroids, alphablocker or antiglaucoma medication history of previous or current systemic steroid use history of uveitis mature cataract H25.0 Age-related incipient cataract Prevention Prevention Placebo Placebo Intervention 1: Non-diabetic patients who recieve topical prednisone acetate 1% drop, every six hours, 24 hours before surgery. Patients are advised to shake the bottle before using. The administered drop is produced by Sinadaroo company. Intervention group: Diabetic patients who receive topical prednisone acetate 1% every six hours, 24 hours before surgery. Patients are advised to shake the bottle before using. The administered drop is produced by Sinadaroo company. Control group1: Non-Diabetic patients who receive preservative- free artificial tears every six hours, 24 hours before surgery. The administered drop is produced by Sinadaroo company. Control group2: Diabetic patients who receive preservative- free artificial tears every six hours, 24 hours before surgery. The administered drop is produced by Sinadaroo company. Horizontal pupilary diameter. Timepoint: The diameter of the pupilary horizontal diameter is measured at the beginning and at the end of the operation using caliber and is divided into two groups up and down six millimeters. Method of measurement: Caliber. The score of post-operative pain which is measured by Visual Analog Scale for pain questionnaire. Timepoint: 24 hours after surgery. Method of measurement: Score of Visual Analog Scale for pain questionnaire. Post operative photophobia. Timepoint: 24 hours after surgery. Method of measurement: Visual Analogue Scale for pain questionnaire. Foreign body sensation. Timepoint: 24 hours after surgery. Method of measurement: Visual Analogue Scale for pain questionnaire. Itching. Timepoint: 24 hours after surgery. Method of measurement: Visual Analogue Scale for pain questionnaire. Mashhad University of Medical Sciences Approved 2017-01-28 Ethics committee of Mashhad University of Medical Sciences Khatamolanbia Hospital, Gharani street Mashhad Razavi Khorasan Iran (Islamic Republic of)