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IRCT20200829048553N1 IRCT 2021-05-31 Semnan University of Medical Sciences Effect of tropicamide 0.5% vs tropicamide 1% on intraocular pressure of diabetic patients Comparison of the effect of tropicamide 0.5% and tropicamide 1% on intraocular pressure, pupil size, keratometry and anterior chamber parameters in patients with type 1 and type 2 diabetes mellitus 2021-06-22 anticipated 210 Complete https://irct.ir/trial/55861 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: The drops are instilled into the patients' eye by a nurse. Study participants are unaware of the type of medication used. The outcome assessor (ophthalmologist) does not know the type of medication used for each patient. The data is analyzed by an biostatistician. He or she also does not know the type of drug used for each patient. 3 Condition 1: Type 2 diabetes mellitus. Condition 2: Type 1 diabetes mellitus. Intervention 1: Intervention group: this group receives tropicamide 0.5% (one drop every 5 minutes for 2 times) drops. Intervention 2: Intervention group: this group receives tropicamide 1% (one drop every 5 minutes for 2 times) drops. 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: Researchers can use the data for systematic review studies and meta-analysis. 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 Navis Elmi Sadr
Kowsar Semnan Research and Medical Training Center, semnan, iran
semnan Iran (Islamic Republic of) 3519899951 +98 23 3343 7824 navid.elmi.sadr@gmail.com Semnan University of Medical Sciences scientific Navid Elmi Sadr
Kowsar Semnan Research and Medical Training Center, semnan, iran
semnan Iran (Islamic Republic of) 3519899951 +98 23 3343 7824 navid.elmi.sadr@gmail.com Semnan University of Medical Sciences Iran (Islamic Republic of) Patients with Diabetes Mellitus type 1 and 2 21 years no limit Both Proliferative diabetic retinopathy History of cataract surgery severe nuclear and cortical cataract Glaucoma Intraocular pressure (IOP) greater than 21 mmHg Familial history of glaucoma Narrow angle (Van Herick 1, 2) Cup to disc ratio greater than 0.5 Pregnancy Pterygium Corneal ectasia History of keratorefractive surgery Corneal dystrophy Iris disorders Anisocoria Iris neovascularization Use of miotics or mydriatics E11 E10 Type 2 diabetes mellitus Type 1 diabetes mellitus Treatment - Drugs Treatment - Drugs Intervention group: this group receives tropicamide 0.5% (one drop every 5 minutes for 2 times) drops. Intervention group: this group receives tropicamide 1% (one drop every 5 minutes for 2 times) drops. Intraocular pressure (IOP). Timepoint: Before intervention, 30 minutes after intervention. Method of measurement: Goldmann applanation tonometry. Pupillary diameter. Timepoint: Before intervention, 30 minutes after intervention. Method of measurement: Scheimpflug camera (Oculus Pentacam); Autorefractokeratometer (TOMEY RC-5000 and Topcon KR-1);. Keratometry. Timepoint: Before intervention, 30 minutes after intervention. Method of measurement: Scheimpflug camera (Oculus Pentacam); Autorefractokeratometer (TOMEY RC-5000 and Topcon KR-1);. Anterior chamber parameters. Timepoint: Before intervention, 30 minutes after intervention. Method of measurement: Scheimpflug camera (Oculus Pentacam). NCT04932213 www.ClinicalTrials.gov Semnan University of Medical Sciences Approved 2021-04-27 Ethics committee of semnan university of medical sciences Headquarter of Semnan University of Medical Sciences and Health Services, Bassij Blvd, Semnan, Iran semnan Semnan Iran (Islamic Republic of)