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IRCT20220423054625N1 IRCT 2023-10-28 Oroumia University of Medical Sciences Investigating the effect of topical diclofenac in diabetic macular edema Comparison of clinical outcomes after combined therapy of bevacizumab intravitreal injection and topical diclofenac with bevacizumab intravitreal injection alone in diabetic macular edema 2023-12-21 anticipated 50 Complete https://irct.ir/trial/73281 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly assigned to one of the intervention or control groups using computer-generated numbers produced by the Random allocation software. Thus, in this software, the number of groups and the total sample size will be entered, and then the "randomization” will be implemented in the block section. Then, the computer-generated number list will be given to the physician, and the physician will assign patients to groups according to the determined order by the software for entry into one of the groups. Thus, the randomization process will continue until the final sample size is reached. 3 Diabetic macular edema. Intervention 1: Intervention group: Patients in the intervention group, in addition to receiving the standard treatment, which includes intravitreal injection of 1.25 mg of bevacizumab at the first visit and in the first, second and third months, will take 1 drop of topical diclofenac 1% 4 times a day. Intervention 2: Control group: Patients in the control group will receive the only standard treatment that includes intravitreal injection of 1.25 mg bevacizumab at the first visit and in the first, second and third months. Yes - There is a plan to make this available What will be shared: All data can be shared after de-identifying individuals. When: After the article is published To whom: Aََcademic Researchers Conditions: The data can be accessed as an Excel file and the results as a printed article. Where to obtain: Corresponding author How to obtain: By email address of the corresponding author: gmotarjemizadeh@gmail.com Comments:
public Dr.Gader Motarjemizadeh
Imam Khomeini hospital, Ershad Ave, Modarres Blvd, Urmia, Iran.
Urmia Iran (Islamic Republic of) 57154-89397 +98 44 3245 7286 gmotarjemizadeh@gmail.com Oroumia University of Medical Sciences scientific Dr. Gader Motarjemizadeh
Imam Khomeini hospital, Ershad Ave, Modarres Blvd, Urmia, Iran.
Urmia Iran (Islamic Republic of) 57154-89397 +98 44 3345 7286 gmotarjemizadeh@gmail.com Oroumia University of Medical Sciences Iran (Islamic Republic of) Diabetic patients with non-proliferative diabetic retinopathy and diabetic macular edema Age over 18 years 18 years no limit Both Glaucoma patients Patients with a history of laser therapy Patients with significant media opacity Infection and inflammation of the anterior canine of the eye E08.331 Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema Treatment - Drugs Treatment - Drugs Intervention group: Patients in the intervention group, in addition to receiving the standard treatment, which includes intravitreal injection of 1.25 mg of bevacizumab at the first visit and in the first, second and third months, will take 1 drop of topical diclofenac 1% 4 times a day. Control group: Patients in the control group will receive the only standard treatment that includes intravitreal injection of 1.25 mg bevacizumab at the first visit and in the first, second and third months. Macula central thickness. Timepoint: Before the intervention and one and three months after the intervention. Method of measurement: Optical Coherence Tomography (OCT). Visual acuity. Timepoint: Before the intervention and one and three months after the intervention. Method of measurement: Snellen chart. Intraocular pressure. Timepoint: Before the intervention and one and three months after the intervention. Method of measurement: Tonometer. Oroumia University of Medical Sciences Approved 2023-05-14 Ethics Committee of Imam Khomeini University hospital- Urmia University of Medical Sciences Imam Khomeini hospital, Ershad Ave, Modarres Blvd, Urmia, Iran. Urmia West Azarbaijan Iran (Islamic Republic of)