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IRCT20240213060989N1 IRCT 2024-03-04 Ahvaz University of Medical Sciences Investigating the effect of vitamin A ophthalmic ointment on reducing pain after refractive keratectomy surgery Investigating the effect of vitamin A ophthalmic ointment on reducing pain and accelerating the recovery of corneal abrasions after photorefractive keratectomy 2024-02-29 anticipated 56 Complete https://irct.ir/trial/75476 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Allocation of patients randomly (using permutation blocks) into two intervention and witness groups (14 people) in such a way that patients will participate in the study with knowledge and consent, based on this, the number of patients who will undergo surgery There are 28 people. PRK was performed by a surgeon and will be included in the study. Then, in these patients, in one eye, routine betas from the family of chloramphenicol, betamethasone and artificial tears (control group) and in the other eye as an intervention group, in addition to routine drugs, received Vitamin A Sterile Eye Ointment from Iran Nazo brand requires every 8 hours to a month and can explain to the drugs that it is possible to take the drug as a drug, then from surgery for patients who want to be able to relieve their pain afterwards. Do. (6 and 24 hours after the operation, 12 and 24 hours after the operation and then daily up to a week) and the time period when the pain starts after the operation and requires the use of painkillers after that and the number of painkillers It consumes extra. Register themselves in the checklist that will be delivered to them on the day of the operation. 3 Pain reduction after Photorefractive keratectomy surgery. Intervention 1: control group: In these patients, routine drugs such as chloramphenicol, betamethasone and artificial tears are used randomly in one eye every 8 hours for a month. Intervention 2: Intervention group: In the other eye, as an intervention group, in addition to routine medications, they will receive vitamin A sterile eye ointment from Iran Nazo brand every 8 hours for a month. 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 Still undecided - no release schedule yet
public Maryam Hajizadeh
24 metery street, east sahely highway, ahvaz
Ahvaz Iran (Islamic Republic of) 6193673166 +98 916 131 3548 hajizadeh-m@ajums.ac.ir Ahvaz University of Medical Sciences scientific Maryam Hajizadeh
24 metery street, east sahely highway, ahvaz
Ahvaz Iran (Islamic Republic of) 6193673166 +98 916 131 3548 hajizadeh-m@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Class I and II of the American Society of Anesthesiology People with refractive error myopia and regular astigmatism (both together or each one alone) The optical amount of the zone is 5.6 - 5.7 People with spherical equivalent maximum 3.5 diopters no limit no limit Both Lack of consent to participate in the study Use of contact lenses in the last two months Presence of corneal scratch before surgery taking medication Corneal dystrophies The presence of any structural disorder of the eye Pathology and eye diseases Existence of systemic diseases (diabetes, vascular collagen disorder, etc.) People with hyperopia, amblyopia Treatment - Drugs Treatment - Drugs control group: In these patients, routine drugs such as chloramphenicol, betamethasone and artificial tears are used randomly in one eye every 8 hours for a month. Intervention group: In the other eye, as an intervention group, in addition to routine medications, they will receive vitamin A sterile eye ointment from Iran Nazo brand every 8 hours for a month. Visual Analog Scale (VAS). Timepoint: Immediately after the operation, 6, 12 and 24 hours. Method of measurement: It will be quantitatively recorded from 0 (no pain) to 5 (very intense pain that is excruciating). Corneal scratch. Timepoint: Examination by hand-held slit lamp In the daily visits after the surgery (until the complete recovery of the corneal scratch) and then a re-visit will be done one week after the surgery. Method of measurement: Based on mm. Time of onset of first pain. Timepoint: Based on the patient condition checklist. Method of measurement: Time of onset of first pain after surgery. Patient's eye complaint. Timepoint: Based on the patient condition checklist. Method of measurement: subjectively and comparing binoculars. Ahvaz University of Medical Sciences Approved 2024-01-27 Research Ethics Committee of Jundishapur University of Medical Sciences, Ahvaz Jundishapur University of Medical SciencesŲŒ Koi GolestanŲŒ Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)