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

NCT04242719 | Completed DMC

• 1 other identifier: 17-1177-18
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the efficacy of retinal electromagnetic stimulation and sub-tenon autologous platelet rich plasma in the treatment of deep retinal capillary ischemia.

Conditions

Deep Retinal Capillary Ischemia; Paracentral Acute Middle Maculopathy; Acute Macular Neuroretinopathy

Keywords

Deep retinal capillary ischemia; Paracentral acute middle maculopathy; Acute macular neuroretinopathy; Electromagnetic stimulation; Magnovision; Platelet-rich plasma

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (3)

Only electromagnetic stimulation

ACTIVE COMPARATOR

Only rEMS was preferred as the initial step

Device: Electromagnetic stimulation

Combined with electromagnetic stimulation and PRP

ACTIVE COMPARATOR

Order to augment the effect of the rEMS, sub-tenon aPRP injection was added.

Device: Electromagnetic stimulation; Biological: Platelet rich plasma

Natural course

NO INTERVENTION

Served as control group, and existing systemic disorder(s) were consulted and treated accordingly.

Interventions

Electromagnetic stimulation DEVICE

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.

Also known as: Magnovision

Combined with electromagnetic stimulation and PRP; Only electromagnetic stimulation

Platelet rich plasma BIOLOGICAL

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.

Also known as: Autologous PRP

Combined with electromagnetic stimulation and PRP

Eligibility Criteria

• Age: 15 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients complaining of blurred vision and/or acute-onset paracentral scotoma during the last month without any visible fundus change along with typical SD-OCT and OCTA findings.

You may not qualify if:

• The presence of noticeable changes in the fundus examination,
• Any optic media opacity that may cause artefacts on OCTA images and interfere with quantitative measurements of the DCP vessel density,
• Complaining of paracentral scotoma lasting more than 1 month (in order to exclude chronic changes in the retinal tissue),
• Presence of atrophic changes in INL or ONL on cross-sectional B-scan SD-OCT

Sponsors & Collaborators

• Ankara Universitesi Teknokent: lead

Study Sites (1)

Ankara University Biotechnology Institute

Ankara, Türkiye, 06312, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 26562176 BACKGROUND

• 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.

  PMID: 29546474 BACKGROUND

• 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.

  PMID: 28230741 BACKGROUND

• 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.

  PMID: 31385285 RESULT

MeSH Terms

Conditions

White Dot Syndromes

Condition Hierarchy (Ancestors)

Uveitis, Posterior; Panuveitis; Uveitis; Uveal Diseases; Eye Diseases

Study Officials

• Umut Arslan, MD

  Ankara Universitesi Teknokent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator, MD

Model Details: Prospective, open-label, comparative

Study Record Dates

• First Submitted: January 20, 2020
• First Posted: January 27, 2020
• Study Start: January 1, 2018
• Primary Completion: January 30, 2019
• Study Completion: February 28, 2019
• Last Updated: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)