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IRCT20130306012724N5 IRCT 2021-01-27 Esfahan University of Medical Sciences Trans Epithelial PRK for Treatment of High Astigmatic Error Efficacy and Safety of Trans Epithelial Compared to Conventional Photorefractive Keratectomy for Treatment of Astigmatism of more than 3 Diopters. 2020-11-21 anticipated 40 Complete https://irct.ir/trial/53419 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In a contralateral design, one eye of each subject will be assigned randomly to the study group, and the other eye of the same patient be assigned to the control group, by Random Allocation Software. Random allocation table created by “Random Allocation Software” version 1.0.0 (developed by M. Saghaei, MD, Isfahan University of Medical Sciences). The number of groups set at 2 (namely OD, and OS), sample size: 40, on only one block, to find which eye of the sequential case numbers will be assigned to the intervention group. The excimer device operator will have the random table; at the time of surgery, one eye will be assigned to the intervention group, and the contralateral eye to the control group, according to the allocation table, Blinding description: Subjects know eyes will be operated with two techniques, they will not know which eye is operated by which way. The outcome assessor and data analyzer will be blinded with regard to grouping. N/A Condition 1: Myopia. Condition 2: Astigmatism. Intervention 1: Intervention group: Trans-epithelial PRK for treatment of myopic astigmatism with SCHWIND AMARIS 1050RS (eye-tech-solutions, Kleinostheim, Germany) excimer laser system. Intervention 2: Control group: Conventional PRK for treatment of myopic astigmatism with SCHWIND AMARIS 1050RS (eye-tech-solutions, Kleinostheim, Germany) excimer laser system aberration free profile. Yes - There is a plan to make this available What will be shared: All collected deidentified IPD When: Starting 6 months after publication To whom: All researchers who are interested Conditions: Selected researchers Where to obtain: Contact principal investigator How to obtain: Maximum one month after contacting the principal investigator Comments:
public Leila Babaei
Feiz hospital, Modares Street
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3445 2031 Leila8969@gmail.com Esfahan University of Medical Sciences scientific Alireza Peyman
Feiz hospital, Modares Street
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3445 2031 peyman@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Age over 18 years Stable refraction during the last year No history of wearing contact lens for at least 3 weeks before the examination No history of Keratoconus and any type of corneal ectasia in the patient or his first-degree family sphere equal to or greater than -1 diopter and cylinder equal to or greater than 3 diopters in both eyes Satisfaction and full knowledge of patients to enter the plan 18 years no limit Both Previous ocular surgery Active eye disease, corneal dystrophy, retinal diseases, glaucoma, dry eye of any degree History of severe eye trauma Systemic diseases that potentially impair wound healing, including diabetes, collagen vascular disease, and pregnancy. Taking inhaled or systemic steroids actively or for 3 months before the procedure H52.13 H52.203 Myopia, bilateral Unspecified astigmatism, bilateral Treatment - Surgery Treatment - Surgery Intervention group: Trans-epithelial PRK for treatment of myopic astigmatism with SCHWIND AMARIS 1050RS (eye-tech-solutions, Kleinostheim, Germany) excimer laser system. Control group: Conventional PRK for treatment of myopic astigmatism with SCHWIND AMARIS 1050RS (eye-tech-solutions, Kleinostheim, Germany) excimer laser system aberration free profile. Refractive astigmatism. Timepoint: Before, and 6 months after intervention. Method of measurement: Autorefractometry, combined with subjective refinement. Visual acuity. Timepoint: Before, and 6 months after intervention. Method of measurement: Snellen chart. Cornea slit-lamp examination. Timepoint: before, and 6 months after intervention. Method of measurement: Slit-lamp bio-microscopy. Esfahan University of Medical Sciences Approved 2020-10-24 Ethics committee of Isfahan University of Medical Sciences Hezarjerib Street Isfahan Isfehan Iran (Islamic Republic of)