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

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

Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 18 patients. In order to randomize, the block randomization method will be used.

In this study, all patients with renal impairment who referred to Shafa Hospital will be enrolled. Patients will be randomly divided into 3 groups based on 6 blocks. The sample size for each study group is 6. A total of 18 patients will be examined. Patients, doctor and data analyzer will be blind.

Inclusion criteria: patients over 18 years, Corneal staining, Schirmer test is less than 5 mm in 5 minutes, BUT test is less than 5 seconds. Exclusion criteria: pregnancy, lactation, history of glaucoma and previous surgery or trauma, use of eye drops except for artificial tears, use of contact lenses.

Intervention group 1: Patients receive only artificial tear drops Intervention group 2: Patients receive only tacrolimus drops Intervention group 3: Patients receive a combination of tacrolimus drops with PRP

BUT test; Corneal staining; Schirmer test

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.

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.