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IRCT20211011052725N1 IRCT 2021-12-24 Kerman University of Medical Sciences Effect of tacrolimus drops and PRP in the treatment of chronic dry eye Simultaneous effect of tacrolimus drops and PRP and its comparison with artificial tacrolimus drops in the treatment of chronic dry eye in patients referred to the hospital 2022-01-10 anticipated 18 Complete https://irct.ir/trial/59262 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly divided into three groups. Randomization tool will be random sequence generation software that in addition to simple randomization, these random sequence generation software are able to generate random sequence by blocking method. In order to randomize, the block randomization method will be used. Block randomization is to make sure that exactly the same number of participants enter the study groups. The advantage of block randomization is that the balance of the number of participants in each group is guaranteed. For this purpose, 6 blocks will be formed and in each block, 2 people from intervention group 1, 2 people from intervention group 2 and 2 people in intervention group 3 will be placed. A total of 3 blocks will be considered to reach the sample size. For concealment, random allocation concealment will be used, which is the method used to execute a random sequence on the study participants, so that the assigned group is not known before the individual is assigned. Using opaque envelopes sealed with a random sequence, in this method, each of the random sequences created is recorded on a card and the cards are placed inside the envelopes in order. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the letter envelopes are glued and placed in a box, respectively. the door At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes of the letter is opened in order and the assigned group of the participant is revealed, Blinding description: Patients will be unaware and blind to the type of drugs. In order to blind, the desired drops are provided to patients in similar packages and in coded form, and patients will not be aware of the content of their medication. Patients will be aware that they will be randomly assigned to one of three treatment groups, but will be unaware of which treatment will be provided in that group. The physician also knows that patients will be anesthetized in three different ways, but will not know which procedure will be performed for each patient. The data collection officer, analyst and outcome assessor will collect and analyze information based on groups 1, 2 and 3 and will not be aware of the type of treatment provided in the groups. They will be kept blind. 2 Dry eye syndrome. Intervention 1: Intervention group 1: Patients receive only artificial tear drops. Patients will use one drop three times a day, each time at eight-hour intervals. 10 ml drops will be for a patient's dose of one month. This amount will be repeated for the second and third month. Intervention 2: Intervention group 2: Patients receive only tacrolimus drops. One mg of tacrolimus is dissolved in five mg of buffer phosphate and given to the patient in sterile eye drops. Patients will use one drop three times a day, each time at eight-hour intervals. 10 ml drops will be for a patient's dose of one month. This amount will be repeated for the second and third month. Intervention 3: Intervention group 3: Patients receive a combination of tacrolimus drops with PRP. One mg of tacrolimus is dissolved in 5 mg of buffer phosphate and after mixing with 5 ml of autologous PRP in sterile eye drops will be given to the patient. Patients will use one drop three times a day, each time at eight-hour intervals. 10 ml drops will be for a patient's dose of one month. This amount will be repeated for the second and third month.
public Farzaneh Barzegarpur
No.25, Emam Reza blv, Rafsanjan
Kerman Iran (Islamic Republic of) 7618751151 +98 34 3428 2227 barzegarf1368@yahoo.com Kerman University of Medical Sciences scientific Farzaneh Barzegarpur
No.25, Emam Reza blv, Rafsanjan
Kerman Iran (Islamic Republic of) 7618751151 +98 34 3428 2227 barzegarf1368@yahoo.com Kerman University of Medical Sciences Iran (Islamic Republic of) Patients over 18 years Corneal staining Schirmer test is less than 5 mm in 5 minutes BUT test is less than 5 seconds. 18 years no limit Both Pregnancy Lactation Pregnancy, lactation, history of glaucoma and previous surgery and trauma Use of eye drops other than artificial tears, and use of contact lenses. H04.12 Dry eye syndrome Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: Patients receive only artificial tear drops. Patients will use one drop three times a day, each time at eight-hour intervals. 10 ml drops will be for a patient's dose of one month. This amount will be repeated for the second and third month. Intervention group 2: Patients receive only tacrolimus drops. One mg of tacrolimus is dissolved in five mg of buffer phosphate and given to the patient in sterile eye drops. Patients will use one drop three times a day, each time at eight-hour intervals. 10 ml drops will be for a patient's dose of one month. This amount will be repeated for the second and third month. Intervention group 3: Patients receive a combination of tacrolimus drops with PRP. One mg of tacrolimus is dissolved in 5 mg of buffer phosphate and after mixing with 5 ml of autologous PRP in sterile eye drops will be given to the patient. Patients will use one drop three times a day, each time at eight-hour intervals. 10 ml drops will be for a patient's dose of one month. This amount will be repeated for the second and third month. BUT test (Fluorescein disappears from Fornix). Timepoint: One week, one month and three months after starting treatment. Method of measurement: Clinical examination of the patient - per second. Corneal staining. Timepoint: One week, one month and three months after starting treatment. Method of measurement: Clinical examination of the patient. Schirmer test. Timepoint: One week, one month and three months after starting treatment. Method of measurement: Clinical examination of the patient - In millimeters per minute. Kerman University of Medical Sciences Approved 2020-04-27 Ethics committee of Kerman University of Medical Sciences Shafa Educational and Medical Center, Kowsar Boulevard Kerman Kerman Iran (Islamic Republic of)