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IRCT20221026056315N1 IRCT 2023-01-28 Zahedan University of Medical Sciences Comparison of optic nerve head perfusion in diabetic patients undergo conventional and micropulse macular photocoagulation in patients Comparison of optic nerve head perfusion in diabetic patients undergo conventional and micropulse macular photocoagulation 2023-02-19 anticipated 50 Complete https://irct.ir/trial/66635 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Use simple randomization,use the table of random number, even number will be assigned to micropulse intervention and odd number to conventional. Randomization unit individual, Blinding description: People from the research team who are responsible for the selection and randomization of patients will not be included in the other stages of the research, especially the examination of people in terms of the dependent variable. Also, the consent form was filled and the procedure was explained, the patients and their companions will divided without knowing that they were in the intervention or control groups. N/A Non proliferation diabetic patients with macula edema. Intervention 1: Intervention group1 : Diabetic pations with macula edema one time under micropulse photocoagulation. This device (manufactured by Quantel Medial, USA) will be used with an adjustable power starting at 1000 mV with a duration of 300 µs and a duty cycle of 15% and a spot size of 500 µm. Intervention 2: Intervention group2: Diabetic pations with macula edema one time under convetional photocoagulation. Conventional laser photocoagulation (Quantel-medical Co, USA) will be performed via dilated pupil in eyes of second group as described below: adjustable power with 50 to 100 microns spot size, 0.1 second duration time. Focal laser will be applied in distance of 500 to 3000 microns of the foveal avascular zone (FAZ) and also on microvascular lesions of the exudative ring, also grid laser will be applied on thickened retinal areas in 500 microns distance of the FAZ and 500 microns distance of temporal ridge of optic disc. 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 No more information.
public Maryam Zeighami
No.48, Shohada street.
Ardabil Iran (Islamic Republic of) 5619745741 +98 45 3323 8337 maryamzeighami@yahoo.com Zahedan University of Medical Sciences scientific Maryam Zeighami
No.48, Shohada street
Ardabil Iran (Islamic Republic of) 5619745741 +98 45 3323 8337 maryamzeighami@yahoo.com Zahedan University of Medical Sciences Iran (Islamic Republic of) non proliferative diabetic retinopathy patients with macula edema 30 years no limit Both Intravitrea drug injection E08.341 Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema Treatment - Other Treatment - Other Intervention group1 : Diabetic pations with macula edema one time under micropulse photocoagulation. This device (manufactured by Quantel Medial, USA) will be used with an adjustable power starting at 1000 mV with a duration of 300 µs and a duty cycle of 15% and a spot size of 500 µm. Intervention group2: Diabetic pations with macula edema one time under convetional photocoagulation. Conventional laser photocoagulation (Quantel-medical Co, USA) will be performed via dilated pupil in eyes of second group as described below: adjustable power with 50 to 100 microns spot size, 0.1 second duration time. Focal laser will be applied in distance of 500 to 3000 microns of the foveal avascular zone (FAZ) and also on microvascular lesions of the exudative ring, also grid laser will be applied on thickened retinal areas in 500 microns distance of the FAZ and 500 microns distance of temporal ridge of optic disc. Optic head perfusion. Timepoint: Befor conventional and micropulse photocoagulation -one month, 3 month and 6 month after conventional and micropulse photocoagulated. Method of measurement: Optical coherence tomography angiography(OCTA). Zahedan University of Medical Sciences Approved 2022-09-18 Ethics committee of zahedan university of medical sciences Alzahra eye hospital, Motaheri steet Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)