Transorbital electrical stimulation as a vision restoration tool in patients with significant optic atrophy due to primary open-angle glaucoma. Acronym: VIROA (Vision Restoration in Optic Atrophy)
Organizational Data
- DRKS-ID:
- DRKS00029129
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2022-11-10
- Last update in DRKS:
- 2024-02-02
- Registration type:
- Prospective
Acronym/abbreviation of the study
VIRON (Vision Restoration in Optic Neuropathy)
URL of the study
https://augenklinik-goettingen.de/forschung/klinische-forschung
Brief summary in lay language
In this study, we present a new, non-invasive treatment method for patients with primary open-angle glaucoma. Glaucoma is a progressive disease of the optic nerve that, over time, leads to visual field defects. So far, the progression of the disease can only be slowed down by lowering the intraocular pressure. The therapy concept used in the study is a non-invasive electrical stimulation procedure that is used with the aim of reducing visual field defects that has already occurred and thus improving the patient's visual performance. A total of 300 study participants will be randomly divided into three parallel groups. Group 1 receives classic electrostimulation, group 2 nuclear spin-based, individually optimized electrostimulation and group 3 sham stimulation. The stimulation treatment is carried out for 10 consecutive days (weekends excluded).
Brief summary in scientific language
In this study, we present a new, non-invasive treatment method for patients with primary open-angle glaucoma. Primary open-angle glaucoma is characterized by progressive retinal ganglion cell loss associated with optic neuropathy and subsequent visual field defects. So far, the progression of the disease can only be slowed down by lowering the intraocular pressure. The therapy concept used in the study is a non-invasive electrical stimulation that is used with the aim of reducing already existing field defects and thus improving the patient's visual performance. A total of 300 study participants will be randomized into three parallel groups. Group 1 receives classic electrical stimulation, group 2 magnetic resonance imaging-based, individually optimized electrical stimulation, and group 3 sham stimulation. The stimulation treatment is carried out for 10 consecutive days (weekends excluded).
Health condition or problem studied
- ICD10:
- H40.1 - Primary open-angle glaucoma
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Classic transorbital electrostimulation is carried out using 2 electrodes placed in the area of the temples. The desired line of sight of the patient is straight ahead. Duration per stimulation unit: 25 minutes
- Arm 2:
- Group 2 receives individualized electrical stimulation based on a MRI scan. The electrode positioning and the desired line of sight during the stimulation are individually adjusted to the location of the optic nerve damage after prior analysis of an MRI data set and location of the visual field defects. Duration per stimulation unit: 25 minutes
- Arm 3:
- Group 3 receives sham stimulation. The majority of patients from group 3 receives transorbital sham stimulation via 2 electrodes placed in the area of the temples, comparable to group 1. The desired line of sight of the patients is directed straight ahead. In order to maintain the blinding, around 10% of the patients are given sham stimulation with individually adjusted electrode positioning and the desired line of sight during the stimulation, comparable to group 2. Duration per stimulation unit: 25 minutes
Endpoints
- Primary outcome:
- The primary aim of this clinical study is to examine the effectiveness of the classic electrical stimulation method by comparing it with sham stimulation. For this purpose, the mean defect (MD) immediately after the treatment (days 9, 16 and 23) is compared with the values of the initial examination (days -21, -14 and 0) (analysis of the short-term effect).
- Secondary outcome:
- - Success of individualized electrostimulation: change in MD between initial examination (days -21, -14 and 0) and measurement after treatment (days 9, 16 and 23) compared to sham and classic electrostimulation - Long-term effect: change in MD 24 weeks (day 149 + 3 days) after classic electrostimulation, individualized electrostimulation and sham stimulation in relation to the initial examination - Questionnaire on subjective changes in vision (NEI-VFQ-25): analysis of group differences and changes over time after the last stimulation (day 9) and after 24 weeks compared to the baseline examination (day -14) - Quality of Life Impact Questionnaire (SF-36): Analysis of group differences and changes over time after the last stimulation (Day 9) and after 24 weeks compared to baseline (Day -14)
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Placebo
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- Yes
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
-
- Assessor
- Caregiver
- Data analyst
- Investigator/therapist
- Patient/subject
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- University medical center Augenklinik der Universitätsmedizin Göttingen Göttingen
- University medical center Augenklinik der Universitätsmedizin Mainz Mainz
- University medical center Klinik für Augenheilkunde des UKE Hamburg Hamburg
- University medical center Augenklinik des Universitätsklinikums Bonn Bonn
- University medical center Zentrum für Augenheilkunde der Uniklinik Köln Köln
Recruitment period and number of participants
- Planned study start date:
- 2023-06-19
- Actual study start date:
- 2023-07-14
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 300
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 40 Years
- Maximum Age:
- 79 Years
- Additional Inclusion Criteria:
- - Patients with diagnosis of primary open-angle glaucoma (according to the EGS criteria), glaucomatous optic atrophy and significant visual field impairment typical for glaucoma (mean defect >5dB) - Age >/= 40 years - Typical glaucomatous optic disc damage and visual field loss in one eye and either visual field loss or typical glaucomatous optic disc damage or both in the other eye - Familiarity with static perimetry (at least 5 examinations before starting this study) - Intraocular pressure <22 mmHg (topically treated or untreated) - signed informed consent and willingness to participate
Exclusion Criteria
- any other type of glaucoma except POWG - Age > 80 years - Visual field defect (mean defect) >/= 22dB or <5dB - Visual acuity decimal <0.2 - Deviation of the mean defect (MD) of >2dB between screening (day -28) and the first initial examination (day -21) - Vision-related affection of the refracting media (e.g., cataract or corneal scars) that would affect the assessment of study effects - other ophthalmological reasons for visual impairment (e.g. age-related macular degeneration, diabetic retinopathy, optic atrophy of other origins apart from POAG, vascular occlusion) - any surgical procedure within 3 months prior to study entry - Status post glaucoma surgery or eye pressure-reducing laser or cryotherapy within 3 months prior to study entry - Status post intraocular surgery within 6 months prior to study entry - Any glaucoma medication change within 3 months prior to study entry and/or use of more than 2 local (or oral) antihypertensive drugs at baseline - Refractive error: spherical equivalent greater than +/-6dpt, cylinder value greater than 3dpt - Patients with comprehensible visual field impairments caused by ptosis or dermatochalasis. - Women of childbearing age without contraception, pregnancy, breastfeeding mothers - neurological diseases (stroke, seizures, epilepsy, status post brain surgery, pathological nystagmus) - uncontrolled high blood pressure (>160 mmHg) - Claustrophobia - Electronic implants (e.g. pacemakers, brain implants) or metallic artefacts on the head - Mental illnesses (e.g. schizophrenia, addictions, substance dependency) that do not allow the person to assess the nature and scope as well as possible consequences of the clinical study - Inability to understand the nature of the study and provide valid informed consent - Signs that the patient will probably not attend the necessary visits (e.g. lack of willingness to cooperate, lack of compliance) - Participation in other clinical studies within the last 12 weeks before the start of the study - Autoimmune diseases in the acute stage - Acute (intra-)ocular inflammation in the study or companion eye - Therapy with opiates, calcium antagonists or benzodiazepines - Unwillingness for an MRI examination
Addresses
Primary Sponsor
- Address:
- Universitätsmedizin GöttingenRobert-Koch-Straße 4037099 GöttingenGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.humanmedizin-goettingen.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsmedizin GöttingenProf. Dr. Michael SchittkowskiRobert-Koch-Straße 4037075 GöttingenGermany
- Telephone:
- 0551/39-10537
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.humanmedizin-goettingen.de
Contact for Public Queries
- Address:
- Augenklinik der Universitätsklinik GöttingenJohanna PohlnerRobert-Koch-Str. 4037075 GötttingenGermany
- Telephone:
- +49551-3964819
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Universitätsmedizin GöttingenProf. Dr. Michael SchittkowskiRobert-Koch-Straße 4037075 GöttingenGermany
- Telephone:
- 0551/39-10537
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.humanmedizin-goettingen.de
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Deutsche ForschungsgemeinschaftKennedyallee 4053175 BonnGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.dfg.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Universitätsmedizin GöttingenVon-Siebold-Straße 337075 GöttingenGermany
- Telephone:
- +49-551-3961261
- Fax:
- +49-551-3969536
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2022-09-27
- Ethics committee number:
- 19/10/22 (Antragsnummer)
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2022-10-27
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- Yes
- IPD Sharing Plan:
- The study protocol will be published after approval by the ethics committee.
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry