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IRCT20231126060185N1 IRCT 2024-01-09 Zahedan University of Medical Sciences The Effect of Zilomol and Timolol Drop on the Diabetic Macular Edema A Comparative Study of the Effect of Zilomol and Timolol Drop Following Intravitreal Injection of Bevacizumab on the Improvement of Diabetic Macular Edema 2024-02-04 anticipated 34 Complete https://irct.ir/trial/73981 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For each patient, one of the eyes is randomly selected to receive dorzolamide-timolol drops (Zimolol) and the opposite eye receives timolol drops at a dose of one drop every 8 hours. The label of the drops is removed in order to make their shape uniform and the drops are coded with random three-digit numbers (391 and 538) (code 391: dorzolamide-timolol drops/code 538: timolol drops). The person injecting is unaware of which eye the patient is using dorzolamide-timolol and which timolol. At the end, the statistics expert will be presented with the information related to BCVA, CMT and IOP of both eyes in coded form (code 391 and 538), Blinding description: It is blinded in three ways, the patient is not aware of the type of intervention performed, and on the other hand, the doctor evaluating the outcome of the study is also not aware of the type of treatment used. The statistical consultant is also not aware of the type of intervention. Opaque sealed with random sequence is done. In this way, the random sequence is determined first, then the sequences are recorded on a card and the cards are placed inside the envelopes in order. On the outer surface of the envelopes. The numbering is done and it is placed in the box in order. The participants choose an envelope in the order of arrival and the intervention group is determined. N/A Diabetic retinopathy is one of the most important causes of blindness in the world, and due to the fact that it affects people of working age, it has tremendous socio-economic consequences in societies. (1) The prevalence of DME in diabetic patients in Iran is estimated to be around 30%. (DME, Diabetic Macular Edema) can be defined as macular thickening and cystoid edema, which can cause diabetic retinopathy mostly with exudate deposition.. Intervention 1: Intervention group 1: the eye receiving xylomol drops. One day before the intravitreal injection of bevacizumab, drops are placed every 8 hours in the eye that will be injected, and after the injection, they continue every 8 hours for one month and thus To be injected three times and to use intravitreous drops for one month after injection. And after each month of injection, visual acuity, intraocular pressure and central thickness of the macula are measured. Intervention 2: Intervention group: the second eye, recipient of timolol drops, is performed in the same way as the first intervention group. 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 more information
public Maryam Dianat
Motahhary
Zahedan Iran (Islamic Republic of) 98167 37789 +98 54 3329 5725 dianatmaryam60@gmail.com Zahedan University of Medical Sciences scientific Maryam Dianat
Motahhary
Zahedan Iran (Islamic Republic of) 98167 37789 +98 54 3329 5725 dianatmaryam60@gmail.com Zahedan University of Medical Sciences Iran (Islamic Republic of) People with bilateral diabetic macular edema (central retinal thickness more than 300 microns) with center-involved and thickness difference less than 25% between 2 eyes who have not undergone any eye interventions (such as eye surgery, intraocular injection) eye, eye lasers and eye treatment and eye local treatment) are not included. 18 years no limit Both Patients during pregnancy and breastfeeding Active intraocular inflammation treated with topical corticosteroids Eye pathologies such as pterygium or corneal opacities that can affect the evaluation of study variables A patient with high eye pressure who is treated with intraocular pressure lowering drugs and corticosteroids History of allergy to CAIs and sulfonamide drugs Patients who use systemic antihypertensive drugs such as acetazolamide or beta blockers E08.321 Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy with macular edema N/A N/A Intervention group 1: the eye receiving xylomol drops. One day before the intravitreal injection of bevacizumab, drops are placed every 8 hours in the eye that will be injected, and after the injection, they continue every 8 hours for one month and thus To be injected three times and to use intravitreous drops for one month after injection. And after each month of injection, visual acuity, intraocular pressure and central thickness of the macula are measured Intervention group: the second eye, recipient of timolol drops, is performed in the same way as the first intervention group Central thickness of macula. Timepoint: Before intervention-1month -2month-3month post IVB and drop. Method of measurement: - measurement using macular OCT imaging. IOP. Timepoint: Before intervention-1month -2month-3month post IVB and drop. Method of measurement: measurement by Goldman tonometer. Visual acuity. Timepoint: Before intervention and one ,two,three month post. Method of measurement: LogMar. Zahedan University of Medical Sciences Approved 2023-10-17 Ethics committee of zahedan university of medical Sciences Motahhary Street Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)