Management of Deep Retinal Capillary Ischemia by Electromagnetic Stimulation and Platelet- Rich Plasma

NACompletedINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

January 1, 2018

Primary Completion Date

January 30, 2019

Study Completion Date

February 28, 2019

Conditions
Deep Retinal Capillary IschemiaParacentral Acute Middle MaculopathyAcute Macular Neuroretinopathy
Interventions
DEVICE

Electromagnetic stimulation

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.

BIOLOGICAL

Platelet rich plasma

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 A total of 1.5 ml of the middle layer (which mainly contained platelets) was withdrawn by syringe and immediately injected into the sub-tenon space of each eye after topical anesthesia with proparacaine hydrochloride (Alcaine, Alcon, USA) drops.

Trial Locations (1)

06312

Ankara University Biotechnology Institute, Ankara

All Listed Sponsors
lead

Ankara Universitesi Teknokent

OTHER

NCT04242719 - Management of Deep Retinal Capillary Ischemia by Electromagnetic Stimulation and Platelet- Rich Plasma | Biotech Hunter | Biotech Hunter