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IRCT20220424054640N2 IRCT 2022-05-14 Iran University of Medical Sciences Effect of Superficial Keratotomy on Reducing Postoperative Pain Fallowing Conjuctival Flap. Effect of Superficial Keratotomy on Reducing Postoperative Pain Fallowing Conjuctival Flap ;a Randomized Clinical Trial 2022-05-21 anticipated 16 Complete https://irct.ir/trial/63334 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: Patients are divided into two groups. In the first group, we use the classical Gunderson technique as the surgical procedure . In the second group, we use the modified surgical method, the conj flap operation with cutting the superficial nerves of the cornea. All surgeries are performed under general anesthesia. In surgery, a knife is used and the depth of the incisions is enough to reach the midd stroma. Trephinen will also be used in cases where the diameter of the cornea is higher than 8 mm. It will be used and we will cut it. After the pan-pressure operation, pressure will be applied for three days and 5 acetaminophen tablets will be prescribed for all patients with a prescription every 4 hours. If the patient needs more painkillers, in Patient data are recorded. Due to the fact that the patient's eye is bandaged in the first three days, we will not use topical corticosteroids for up to three days after opening the bandage, which coincides with the first visit on the third day after surgery. Topical steroid drops should be started four times a day for the patient and no oral corticosteroids should be used. The title of the cutting guide will be used after the trephinen horizontal and vertical cuts on the surface of the century One will be done by the surgeon with a knife at the same depth of 300. In cases where the diameter of the cornea is less than 8 mm, the surgeon tries to extend the incision depth to the middle of the stroma. After 6 hours, 24 hours and 48 hours after surgery, both groups of patients are asked to express their pain on the VAS scale. Visual analogue scale (VAS) is one of the best methods available for estimating pain intensity. VAS is a 10 cm line printed on a piece of paper with a marker at the end. It is "painless" at one end and "worst pain" or "indescribable pain" at the other. The patient places a mark on the line to indicate pain, and then the mark is measured with a ruler to obtain a score. The mean scores of the two groups are calculated using the Tscore method and finally the mean postoperative pain intensity in the two selected groups will be compared, Randomization description: For random assignment of patients to two groups, random codes in balanced quadruple blocks will be used as follows: 1.AA BB 2.AB AB 3.BB AA 4.BA BA, Blinding description: Researcher number two is responsible for asking how much pain the patient has at 6 24 48 hours after the operation and at the time of question he is unaware that the patient belongs to the intervention or control group. (Blind access). 3 Severe visual impairment, monocular. Intervention 1: Intervention group:we use the modified surgical method, the conj flap operation with cutting the superficial nerves of the cornea. Intervention 2: Control group:we use the classical Gunderson technique as the surgical procedure. Yes - There is a plan to make this available What will be shared: We intend to share the results as an article When: At the end of project 1 year To whom: All Conditions: All academic research Where to obtain: Dr karimi instagram @drnasserkarimi How to obtain: Within 1 week of request Comments:
public Dr.Nasser Karimi
Niyayesh St., Satarkhan St.
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6655 8811 drnasserkarimi@gmai.com Iran University of Medical Sciences scientific Nasser Karimi
Niyayesh street, Satarkhan street
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6655 8811 drnasserkarimi@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) VLE (vision loss eye) Patients who are candidates for prosthesis implantation no limit no limit Both Patients who are candidates for conjunctival flap with indications other than implant placement (such as pain due to corneal ulcers, etc.) painful vision loss eye H54.5 Severe visual impairment, monocular Prevention Prevention Intervention group:we use the modified surgical method, the conj flap operation with cutting the superficial nerves of the cornea. Control group:we use the classical Gunderson technique as the surgical procedure In the study of the effect of superficial corneal incisions in reducing pain in patients after conjunctival flap surgery, primary outcome can be the pain score after Corneal neurotomy . Timepoint: In the study of the effect of superficial corneal incisions in reducing pain in patients after conjunctival flap surgery, pain score measurement can be 6 24 48 hours after corneal neurotomy. Method of measurement: In studying the effect of superficial corneal incisions in reducing pain in patients after conjunctival flap surgery, how to measure pain score can be using VSA(visual analogue scale ). Iran University of Medical Sciences Approved 2022-03-18 Ethics Committee of Iran university of medical sciences Niyayesh St., Satarkhan St. Tehran Tehran Iran (Islamic Republic of)