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IRCT20231125060168N1 IRCT 2023-12-06 Oroumia University of Medical Sciences Comparison of Central Thickness Changes of Cornea in Linear Phacoemulsification with Torsional Phacoemulsification Comparison of Central Thickness Changes of Cornea in Linear Phacoemulsification with Torsional Phacoemulsification Surgery in Cataract Patients 2023-10-26 anticipated 30 Complete https://irct.ir/trial/73927 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: From the patients with cataracts in both eyes who present to Imamkhomeini hospital of Urmia, 30 cases will be chosen based on inclusion or exclusion criteriae. The method used for randomizing the left or the right eye for torsional or linear surgery, is the black box. The box will contain 60 cards and each eye of each patient (left or right) with the name and family name, will be written on one card. Each time, one card will be taken out of the box and each eye of each patient coming out in the first sequence,will undergo surgery with one of the methods; and the eye coming out of the box in second sequence, will undergo surgery with the other type. Determining the method used for the first sequence is by flapping a coin.If the first sequence is torsional, the second sequence will actually be linear or vice versa, Blinding description: The patients who present to the hospital to undergo surgery in both eyes, are blind to the method of surgery on each eye. N/A Central Thickness Changes of Cornea. Intervention 1: The First Intervention Group : The first group consists of 15 patients who undergo torsional phacoemulsification surgery.The central thickness of cornea in each patient is measured, once 24 hours and once 1 week later,using the pachymeter. Intervention 2: The Second Intervention Group : The second group consists of 15 patients who undergo linear phacoemulsification surgery.The central thickness of cornea in each patient is measured, once 24 hours and once 1 week later,using the pachymeter. Intervention 3: Control group: The control group consists of 30 eyes of 15 patients which will undergo surgery in two parallel torsional and linear groups and the central thickness of cornea of each eye will be measured using the pachymeter. 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 No more information available
public Reza Soudi
Ershad Blvd - Imamkhomeini Hospital
Urmia Iran (Islamic Republic of) 8135157157 +98 44 3346 9931 ‏soudi.r@umsu.ac.ir Oroumia University of Medical Sciences scientific Reza Soudi
Ershad Blvd - Imamkhomeini Hospital
Urmia Iran (Islamic Republic of) 8135157157 +98 44 3346 9931 ‏soudi.r@umsu.ac.ir Oroumia University of Medical Sciences Iran (Islamic Republic of) Age over 40 years old Cataracts in both eyes 40 years no limit Both Age under 40 years old corneal pathologies poorly dilating pupil or posterior synechiae pseudoexfoliation subluxated lens retinal pathology glaucoma diabetes mellitus collagen vascular diseases post refractive surgeries H18.23 Secondary corneal edema Treatment - Surgery Treatment - Surgery Diagnosis The First Intervention Group : The first group consists of 15 patients who undergo torsional phacoemulsification surgery.The central thickness of cornea in each patient is measured, once 24 hours and once 1 week later,using the pachymeter. The Second Intervention Group : The second group consists of 15 patients who undergo linear phacoemulsification surgery.The central thickness of cornea in each patient is measured, once 24 hours and once 1 week later,using the pachymeter. Control group: The control group consists of 30 eyes of 15 patients which will undergo surgery in two parallel torsional and linear groups and the central thickness of cornea of each eye will be measured using the pachymeter. Central Corneal Thickness. Timepoint: Before the surgery, 24 Hours later and 1 week later the surgery. Method of measurement: Pachymeter. Best Corrected Visual Acuity. Timepoint: Before Surgery, 24 Hours later and 1 week later the surgery. Method of measurement: Snellen Chart. Oroumia University of Medical Sciences Approved 2023-10-25 Ethics committe of Imamkhomeini Hospital - Urmia University of Medical Sciences Ershad Blvd - Ayatollah Modarres Blvd Urmia West Azarbaijan Iran (Islamic Republic of)