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IRCT20200901048577N1 IRCT 2020-09-23 Semnan University of Medical Sciences Betaxolol 0.5% versus Brimonidine 0.2% prophylactic effect on IOP elevation after Nd: YAG Laser posterior capsulotomy Comparison of prophylactic effect of Betaxolol 0.5% with Brimonidine 0.2% on IOP elevation after Nd: YAG Laser posterior capsulotomy in patients with posterior capsule opacity 2019-08-23 anticipated 40 Complete https://irct.ir/trial/50631 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block Randomization: In this study, the randomized block method is used to allocate the participants into two groups. Each block will have 4 units (2 units related to intervention group and 2 units related to comparison group). There will be 6 different combinations of intervention and comparison in each block. Using the computer-generated random numbers, one of the combinations is selected. In this way, patients are balanced into two groups of intervention and comparison, Blinding description: Patients are randomly allocated into two groups. In group 1, a drop of betaxolol 0.5 % and in group 2, a drop of brimonidine 0.2%, one hour before the laser application, is instilled into the lower fornix by the nurse. The patients do not know the type of the drug (betaxolol or brimonidine). Patients' intraocular pressure is measured and recorded by an ophthalmologist, one hour before laser application and four hours after it. The ophthalmologist also does not know the type of the drug that has been used. The data analysis is performed by an assistant professor of epidemiology and biostatistics who does not know which drug has been used. The information collected by the ophthalmologist and the nurse and the data analysis are given to the student who is responsible for drafting the article. 3 posterior capsule opacification. Intervention 1: Intervention group 1: one drop of betaxolol 0.5% (Sina Darou) is instilled into the lower fornix of the eye, 1 hour before Nd:YAG laser posterior capsulotomy. Intervention 2: Intervention group 2: one drop of brimonidine 0.2 % (Sina Darou) is instilled into the lower fornix of the eye, 1 hour before Nd:YAG laser posterior capsulotomy. Yes - There is a plan to make this available What will be shared: Data can be shared without disclosing the identities of the participants When: Access period starts one year after the results are published To whom: Researchers working in academic and scientific institutions Conditions: There is no more information Where to obtain: Contact the person in charge of the scientific inquiries of the project by e-mail. How to obtain: After receiving the request e-mail, if the person is eligible, the data will be sent. Comments:
public Elnaz Saber
Golestan town , Amin street , Kosar hospital
Semnan Iran (Islamic Republic of) ۳۵۱۹۸۹۹۹۵۱ +98 23 3344 1022 Lnaz_saber@yahoo.com Semnan University of Medical Sciences scientific Navid Elmi Sadr
Golestan town , Amin street , Kosar hospital
Semnan Iran (Islamic Republic of) 3519899951 +98 23 3344 1022 navid.elmi.sadr@gmail.com Semnan University of Medical Sciences Iran (Islamic Republic of) patients with PCO after cataract surgery above 21 years old 21 years no limit Both Patients with glaucoma (or history of glaucoma surgery) cup to disc ratio greater than 0.5 intraocular pressure greater than 21 mmHg active uveitis active ocular infection pregnancy unstable cardiovascular condition severe asthma and lung disease Taking systemic or topical alpha 2 agonists, prostaglandin analogues, parasymapathomimetics, beta-blockers, carbonic anhydrase inhibitors H25 Age-related cataract Treatment - Drugs Treatment - Drugs Intervention group 1: one drop of betaxolol 0.5% (Sina Darou) is instilled into the lower fornix of the eye, 1 hour before Nd:YAG laser posterior capsulotomy. Intervention group 2: one drop of brimonidine 0.2 % (Sina Darou) is instilled into the lower fornix of the eye, 1 hour before Nd:YAG laser posterior capsulotomy. Intraocular pressure. Timepoint: 1 hour before laser application and 4 hours after that. Method of measurement: Goldmann Applanation tonometry. Semnan University of Medical Sciences Approved 2020-08-05 Ethics committee of Semnan University of Medical Sciences Golestan town, Amin street, Kosar hospital semnan Semnan Iran (Islamic Republic of)