Neuroregenerative effects of transorbital extremely low-frequency low-amplitude pulsed electromagnetic therapy in retinal vein occlusion
| ISRCTN | ISRCTN17248612 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17248612 |
| Sponsor | Peoples' Friendship University of Russia |
| Funders | RUDN University, Medical Dental Institute, Russia, I.M. Sechenov First Moscow State Medical University |
- Submission date
- 21/03/2026
- Registration date
- 25/03/2026
- Last edited
- 25/03/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Plain English summary of protocol not provided at time of registration
Contact information
Prof Mustafa Al-Zamil
Scientific, Public, Principal investigator
Scientific, Public, Principal investigator
St. Sherbinka 2-42
Moscow-Sherbinka
108851
Russian Federation
 ORCID ID |
0000-0002-3643-982X |
|---|---|
| Phone | +7 89262893810 |
| alzamil@mail.ru |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Open (masking not used) |
| Control | Active |
| Assignment | Parallel |
| Purpose | Basic science, Device feasibility, Diagnostic, Health services research, Prevention, Screening, Supportive care, Treatment |
| Scientific title | Neuroregenerative effects of transorbital extremely low-frequency low-amplitude pulsed electromagnetic therapy in non-ischemic branch retinal vein occlusion |
| Study acronym | Trabsorbital ELF-LA-PEMT for RVO |
| Study objectives | The purpose of this study is to evaluate the efficacy of transorbital ELF-LA-PEMT combined with intravitreal ranibizumab for the management of Retinal Vein Occlusion (RVO). The study analyzes longitudinal changes in central retinal thickness (CRT), total macular volume (TMV), and best-corrected visual acuity (BCVA) immediately post-treatment and at a three-month follow-up. |
| Ethics approval(s) |
Approved 14/03/2025, Ethic Comittee of Medical Dental Institute (Pskovskaya, 9, Moscow, 127253, Russian Federation; +7 (499) 5045476; medinstmcu@inbox.tu), ref: 185 |
| Health condition(s) or problem(s) studied | Confirmed diagnosis of macular edema secondary to branch retinal vein occlusion or central retinal vein occlusion. |
| Intervention | This research is a two-arm, longitudinal, prospective analysis of patients with non-ischemic superior temporal RVO. Randomization was generated using IBM SPSS Statistics software (version 20). Patients in the intervention group received a course of transorbital ELF-LA-PEMT using a contact ophthalmic emitter applied to the closed affected eye while in a supine position. The therapy involved a continuous, clockwise running magnetic field with an induction of 6 mT and a frequency of 12 Hz. Treatment sessions lasted 20 minutes and were administered on alternate days for a total of 15 sessions. The TMT procedures were initiated one month after the first ranibizumab injection and were carried out over one month. Procedures were conducted using the POLIMAG-02 magnetotherapeutic complex (Elamed, Russia), a specialized system for low-frequency, low-intensity pulsed electromagnetic field (PEMF) therapy. The device (Registration No. RZN 2017/6315, dated October 3, 2017) is manufactured in the Ryazan region, Russia. The control group received anti-VEGF monotherapy only. Central retinal thickness (CRT) and total macular volume (TMV) were measured using optical coherence tomography (OCT) at baseline, as well as at the first and third months post-treatment. BCVA and visual evoked potential (VEP) tests were evaluated at the same intervals. |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | POLIMAG-02 magnetotherapeutic complex |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 01/06/2031 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 40 Years |
| Upper age limit | 70 Years |
| Sex | All |
| Target sample size at registration | 40 |
| Total final enrolment | 200 |
| Key inclusion criteria | 1. European 2. Men and women from 40 to 70 years old 3. Non-ischemic rvo of the superior temporal branch of the central retinal vein 4. Recent onset of retinal vein thrombosis ≤15 days 5. Central retinal thickness: between 350 µm and 600 µm 6. Total macular volume: between 9 mm³ and 15 mm³ |
| Key exclusion criteria | 1. Presence of acute inflammatory diseases of the eye or systemic infections 2. Exudative retinal detachment 3. Poor response to the first anti-vegf injection (decreae of central retinal thickness < 20%) 4. Paroxysmal and mental disorders 5. Systemic thrombophilic disorders 6. Exacerbation of comorbid conditions during the study period 7. Intercurrent illness during the course of treatment 8. History of previously administered antiangiogenic therapy for the current condition 9. Failure to meet follow-up requirements 10. Presence or possibility of pregnancy 11. Decompensation of hypertension and diabetes mellitus 12. History of stroke or multiple sclerosis |
| Date of first enrolment | 19/03/2025 |
| Date of final enrolment | 19/03/2031 |
Locations
Countries of recruitment
- Russian Federation
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Editorial Notes
23/03/2026: Study’s existence confirmed by the Ethics Committee of Medical Dental Institute, Moscow, Russia.
