NCT04242719|CompletedDMC
Management of Deep Retinal Capillary Ischemia by Electromagnetic Stimulation and Platelet- Rich Plasma
rEMS
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rEMS
Sponsor study identifier
interventional
28
1 country
1
Study Start
January 1, 2018
Actual (reported)Primary Completion
January 30, 2019
Actual (reported)Study Completion
February 28, 2019
Actual (reported)To investigate the efficacy of retinal electromagnetic stimulation and sub-tenon autologous platelet rich plasma in the treatment of deep retinal capillary ischemia.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 28, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2018
Actual (reported)January 30, 2019
Actual (reported)February 28, 2019
Actual (reported)January 20, 2020
Actual (reported)January 27, 2020
Actual (reported)Deep retinal capillary vessel density
The vessel densities (in %) of deep capillary plexus were measured with "AngioAnalytic" feature of the OCTA device. To compare the percentage of the vessel densities precisely during follow-up, the "Link-B Scans" button on the screen was activated so that the exact same segmentation planes of the DCP could be compared. The OCTA device automatically calculated and displayed the vessel density maps as follow-up sequences (Angio Retina multiscan view) and trend analysis.
Change from baseline deep reinal capillary vessel density at 1 month.
Best corrected visual acuity
Number of readable letters after glasses correction
Change from baseline best corrected visual acuity at 1 month.
Only rEMS was preferred as the initial step
Order to augment the effect of the rEMS, sub-tenon aPRP injection was added.
Served as control group, and existing systemic disorder(s) were consulted and treated accordingly.
Retinal electromagnetic stimulation A high-frequency repetitive electromagnetic stimulation protocol has been defined in the literature and was applied in groups 1 and group 2 via a novel device developed specifically for ophthalmic usage (Magnovision-TM, Bioretina Biyoteknoloji AŞ, Ankara,Turkey). The patients underwent 10 consecutive sessions of rEMS application. Parameters for the treatment were 42 hertz frequency/min, 30 minutes of duration and mild operating cycle. The power of the electromagnetic field was 2000 milligauss, which is a very low dose and within the safety limits of World Health Organisation. In group 2, sub-tenon aPRP injections were also performed immediately after the first, fifth, and tenth sessions of rEMS application.
Ankara University Biotechnology Institute
Ankara, Türkiye, 06312, Turkey (Türkiye)
Nemiroff J, Kuehlewein L, Rahimy E, Tsui I, Doshi R, Gaudric A, Gorin MB, Sadda S, Sarraf D. Assessing Deep Retinal Capillary Ischemia in Paracentral Acute Middle Maculopathy by Optical Coherence Tomography Angiography. Am J Ophthalmol. 2016 Feb;162:121-132.e1. doi: 10.1016/j.ajo.2015.10.026. Epub 2015 Nov 10.
Arslan U, Ozmert E, Demirel S, Ornek F, Sermet F. Effects of subtenon-injected autologous platelet-rich plasma on visual functions in eyes with retinitis pigmentosa: preliminary clinical results. Graefes Arch Clin Exp Ophthalmol. 2018 May;256(5):893-908. doi: 10.1007/s00417-018-3953-5. Epub 2018 Mar 15.
Umut Arslan, MD
Ankara Universitesi Teknokent
28 participants (actual enrollment reported by the registry).
First Submitted
January 20, 2020
First Posted
January 27, 2020
Study Start
January 1, 2018
Actual (reported)About 20 ml of blood was drawn from the patient's antecubital vein and inserted into two 10-ml vacutainer tubes that contain trisodium citrate (T-LAB PRP Kit, T-Biyoteknoloji, Bursa, TURKEY). These tubes were placed in a refrigerated (+4 °C) centrifuge (Nüve NF 1200R, Nüve Laboratuar Teknolojileri, Ankara, TURKEY) and spun at 2500 rpm (580×g) for 8 min within 30 min of collection. Three different layers formed in the tubes: red blood cells at the bottom, platelet-rich plasma in the middle, and platelet-poor plasma in the top layer. A total of 1.5 ml of the middle layer (which mainly contained platelets) was withdrawn by syringe and immediately injected into the sub-tenon space of each eye after topical anesthesia with proparacaine hydrochloride (Alcaine, Alcon, USA) drops.
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Luo J, Zheng H, Zhang L, Zhang Q, Li L, Pei Z, Hu X. High-Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) Improves Functional Recovery by Enhancing Neurogenesis and Activating BDNF/TrkB Signaling in Ischemic Rats. Int J Mol Sci. 2017 Feb 20;18(2):455. doi: 10.3390/ijms18020455.
Ozmert E, Arslan U. Management of Deep Retinal Capillary Ischemia by Electromagnetic Stimulation and Platelet-Rich Plasma: Preliminary Clinical Results. Adv Ther. 2019 Sep;36(9):2273-2286. doi: 10.1007/s12325-019-01040-2. Epub 2019 Aug 5.
Primary Completion
January 30, 2019
Actual (reported)Study Completion
February 28, 2019
Actual (reported)Last Updated
January 27, 2020
Record last verified: 2020-01
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Source: ClinicalTrials.gov.
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