]>
IRCT20230330057787N1 IRCT 2023-09-04 Zahedan University of Medical Sciences effect of anti-glaucoma agents on intra ocular pressure Spikes after intravitreal bevacizumab injection in patients Investigating the prophylactic effect of antiglaucoma drugs on eye pressure in patients undergoing intravitreal injection of bevacizumab 2023-09-23 anticipated 108 Complete https://irct.ir/trial/72112 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Other, Purpose: Treatment, Other design features: A controlled, single-blind, randomized, phase 3 clinical trial on 108 patients. R statistical software version 4.0.2 was used for randomization, Randomization description: Random assignment of patients to 5 groups is done by permuted stratified randomization method. In this way, first, eligible referring patients are classified according to age and gender in the order of arrival. Then they are randomly assigned to the desired group. These permutations were created using statistical software R version 4.0.2, Blinding description: In this research, single blinding method is used. So that the person responsible for recording the results (eye resident) will not be aware of the intended intervention. 3 Eye pressure of patients undergoing intravitreal injection of bevacizumab. Intervention 1: Intervention group: In the first group, 0.5% topical timolol drops (2 drops with a 10-minute interval, 60-90 minutes before the intervention) are prescribed. Intervention 2: Intervention group: In the second group, the combination of dorzolamide hydrochloride 2% and timolol maleate 0.5% with the brand Xylomol® (2 drops with a time interval of 10 minutes, 60-90 minutes before the intervention) is prescribed. Intervention 3: Intervention group: In the third group, oral acetazolamide 500 mg is administered (90-120 minutes before the intervention). Intervention 4: Control group: In this group, placebo drops (an artificial tear drop, 2 drops with a time interval of 10 minutes, 60-90 minutes before the intervention) are prescribed. 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 There is no further information
public Mr. Dr. Mohammad Erish
Zahedan Motahari Blvd. has not reached Khatam Square of Al-Zahra Ophthalmology Hospital
zahedan Iran (Islamic Republic of) ۹۸۱۶۷۳۷۷۸۹ +98 54 3321 9915 ALzahra_eyecenter@yahoo.com Zahedan University of Medical Sciences scientific Mr. Dr. Mohammad Erish
Zahedan Motahari Blvd. has not reached Khatam Square of Al-Zahra Ophthalmology Hospital
zahedan Iran (Islamic Republic of) 9816737789 +98 54 3321 9915 ALzahra_eyecenter@yahoo.com Zahedan University of Medical Sciences Iran (Islamic Republic of) 1- Age more than 18 years 2- Informed and free consent to participate in the study 3- Patients who will have the first intra-boasizomat injection. 18 years no limit Both 1- History of retinal surgery. 2- Rupture of the posterior capsule 3- High eye pressure or glaucoma 4- Use of topical medication (such as IOP-lowering medications and corticosteroids) 5- Active intraocular inflammation 6- Eye pathologies such as pterygium or corneal opacities that can affect the evaluation of study variables 7- Withdrawal from the study during research for any reason H40.6 Glaucoma secondary to drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Placebo Intervention group: In the first group, 0.5% topical timolol drops (2 drops with a 10-minute interval, 60-90 minutes before the intervention) are prescribed. Intervention group: In the second group, the combination of dorzolamide hydrochloride 2% and timolol maleate 0.5% with the brand Xylomol® (2 drops with a time interval of 10 minutes, 60-90 minutes before the intervention) is prescribed. Intervention group: In the third group, oral acetazolamide 500 mg is administered (90-120 minutes before the intervention). Control group: In this group, placebo drops (an artificial tear drop, 2 drops with a time interval of 10 minutes, 60-90 minutes before the intervention) are prescribed. Intraocular pressure. Timepoint: The beginning of the study / one minute after injection / 30 minutes after injection / 24 hours after injection. Method of measurement: At the beginning of the study, 30 minutes after the injection and 24 hours after the injection, the intraocular pressure is measured with a Goldman tonometer and one minute after the injection with Tonopen. Zahedan University of Medical Sciences Approved 2023-03-01 Ethics Committee of Zahedan University of Medical Sciences Zahedan - Doctor Hasabi Square - Medical Sciences Campus zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)