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IRCT20131229015975N6 IRCT 2020-02-06 Esfahan University of Medical Sciences efficacy of Fluorometholone versus Loteprednol eye drops after photorefractive keratectomy Clinical efficacy of Fluorometholone versus Loteprednol eye drops after photorefractive keratectomy: A triple-blinded randomized clinical trial 2016-04-02 anticipated 100 Complete https://irct.ir/trial/44652 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Both eyes in each subject were randomly allocated to the Fluorometholone (FML) and Loteprednol etabonate (LE) groups using software (Saghaei random allocation software) and simple randomization. According to the random table, each eye individually assigned to one group and the other to the second group, Blinding description: All patients and members of the research team who were involved the study were blinded to the contents of the eye drops. Only the clinical pharmacy technician was aware of the content of each of the eye drops. 3 Condition 1: Myopia correction by photorefractive keratectomy. Condition 2: Astigmatism correction by photorefractive keratectomy. Intervention 1: Intervention group: One eye in each subject was randomly allocated to use of 0.1% Fluorometholone eye drops packaged in droppers (Floucort®, SinaDarou Co., Tehran, Iran) that was prescribed one drop every 6 h for one month. Intervention 2: Control group: The another eye in each subject was randomly allocated to use of the 0.5% Loteprednol sterile ophthalmic suspension packaged in identical droppers (Lotemax®, Bausch & Lomb Inc., Rochester, NY, USA) that was prescribed one drop every 6 hour for one month. Yes - There is a plan to make this available What will be shared: Primary outcome data can be shared. When: Starting 6 months after publication To whom: People working in academic institutions Conditions: Descriptive analysis is allowed on requested data Where to obtain: Mohsen Pourazizi, Department of Ophthalmology, Isfahan University of Medical Sciences, Isfahan, Iran Email: m.pourazizi@yahoo.com How to obtain: The request is discussed in the Center Committee and after approval, the data is submitted to the applicant over a period of approximately one month. Comments:
public Mohsen Pourazizi
Feiz hospital, Modarres Ave., Isfahan, Iran.
Isfahan Iran (Islamic Republic of) 8165647194 +98 31 3445 2031 m.pourazizi@yahoo.com Esfahan University of Medical Sciences scientific Hasan Razmjoo
Feiz hospital, Modarres Ave., Isfahan, Iran.
Isfahan Iran (Islamic Republic of) 8149644874 +98 31 3445 2031 razmjoo@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Stable refraction error for at least 12 months Myopia between −8.0 to −1.0 diopters Astigmatism less than 4.0 diopters Normal eye examination 20 years 40 years Both Unwillingness to participate or continue administration of another topical medication need to increase the topical steroid dosage treatment-related complications H52.10 H52.20 Myopia, unspecified eye Unspecified astigmatism Treatment - Drugs Treatment - Drugs Intervention group: One eye in each subject was randomly allocated to use of 0.1% Fluorometholone eye drops packaged in droppers (Floucort®, SinaDarou Co., Tehran, Iran) that was prescribed one drop every 6 h for one month. Control group: The another eye in each subject was randomly allocated to use of the 0.5% Loteprednol sterile ophthalmic suspension packaged in identical droppers (Lotemax®, Bausch & Lomb Inc., Rochester, NY, USA) that was prescribed one drop every 6 hour for one month. Change in best corrected distance visual acuity (BCDVA). Timepoint: Before intervention and on days one, three, and five and then at months one and three postoperatively. Method of measurement: Eye examination, slit-lamp biomicroscopy and fundus examination assessment. Corneal optical density. Timepoint: Before intervention and on days one, three, and five and then at months one and three postoperatively. Method of measurement: Corneal densitometry was performed with a rotating camera cornea tomography system (Pentacam®). Intraocular pressure. Timepoint: Before intervention and on days one, three, and five and then at months one and three postoperatively. Method of measurement: Goldman applanation tonometry (GAT). Side effects. Timepoint: On days one, three, and five and then at months one and three postoperatively. Method of measurement: Clinical assessment. Esfahan University of Medical Sciences Approved 2016-05-26 Research and Technology Deputy of Isfahan University of Medical Sciences Research and Technology Deputy of Isfahan University of Medical Sciences, Hezar Jerib Avenue, Isfahan Isfahan Isfehan Iran (Islamic Republic of)