GlaucomaEyeYogaNCT04037384
Training of Eye Movements in Glaucoma
A study testing Eye yoga and Passive Reading in people with Glaucoma and Eye Yoga, run by University of Magdeburg at 2 sites in Germany.
Trial summary
The aim of the trial is to investigate the possibilities of improving visual impairments with eye training exercises (eye-yoga) in a total of 40 patients with glaucoma who have not previously been treated within a similar training program. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- Eye yoga and Passive Reading
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Aug 2019to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of glaucoma
- residual vision
- the duration of the disease must be at least 6 months old
- the visual field defect must be stable
Who cannot join
- autoimmune diseases in the acute stage
- neurological and mental diseases
- diabetic retinopathy
- addictions
- hypertension (maximum 160/100 mmHg)
- retinitis pigmentosa-
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- pathological nystagmus
- non-distant tumors or recurrent tumors
- photosensitivity
- pregnancy
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
Inst. of Medical Psychology, Univ. of Magdeburg
Magdeburg, 39120
Bernhard Sabel, Prof. Dr., 0049 (0)3916721 ext. 800, bernhard.sabel@med.ovgu.de
Bernhard Sabel, Prof. Dr.
- Recruiting
Institute of Medical Psychology
Magdeburg, 39120
Bernhard A Sabel, Prof., + 49 391 67 21 800, bernhard.sabel@med.ovgu.de
Sylvia Prilloff, PhD, + 49 391 67 21 807, sylvia.prilloff@med.ovgu.de
About this study
Official title: Alternative Home Training Possibilities for Glaucoma Patients
The aim of the trial is to investigate the possibilities of improving visual impairments with eye training exercises (eye-yoga) in a total of 40 patients with glaucoma who have not previously been treated within a similar training program. 20 patients will be instructed how to do eye yoga to be performed dails for 4 weeks (max 30 min/day). As a control group of 20 patients will be instructed to read for 30 min/day for 4 weeks.
The following outcome measures will be investigated: High Resolution Perimetry, Humphrey Perimetry, Visual Acuity Test, Contrast Sensitivity Test, Microsaccades measurements, Intraocular Pressure Measurement, Electroencephalogram (EEG), Blood Pressure and Pulse Measurement and Dynamic Vessel Analysis (DVA - the blood supply in the eye (especially vascular dysregulation) .
Read more
Furthermore, factors that could influence response variability and the effectiveness of treatment will be analysed: (i) the role of mental stress (or stress resilience) and (ii) the influence of personality traits and quality of life.
The study is intended to further validate this home training program (eye yoga) for the treatment of visual impairment in glaucoma.
Read the detailed description
The aim of eye yoga is to improve microsaccade impairments in patient with primary open angle glaucoma. We will study how this affects visual performance and the physiology of the eye and brain
- Being tested
- Eye yoga, Passive Reading
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye yogaBehavioural
Eye yoga exercises at home given by a trained instructor
Passive ReadingBehavioural
Passive reading at home
| Study group | Role | What they receive |
|---|---|---|
| Eye Yoga group | Active comparator | Eye yoga exercises Receives: Behavioral: Passive Reading |
| Reading Group | Placebo comparator | Passive reading Receives: Behavioral: Eye yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual field size determined by perimetry measurements
Changes of the visual field's size, evaluated by static perimetry and high resolution perimetry measurements
Measured: 4 weeks
Microsaccade measurements
Changes in the deviation of eye movements when visual targets are followed, using a computerized test
Measured: 4 weeks
Secondary outcomes (2)
Blood circulation in the eye
Changes of the diameter of blood vessels in the eye, measured by vessel analysis
Measured: 4 weeks
EEG connectivities
Changes in alpha power using EEG recording (128 channels)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start1 Aug 2019
- Primary completion31 Dec 2022 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Magdeburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bernhard A. Sabel, University of Magdeburg
- Investigators
- Bernhard A Sabel, PhD, Principal investigator, University of Magdeburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04037384
- Sponsor's protocol ID
- UMagdeburg
- Acronym
- EyeYoga
- Status last verified
- Feb 2021
- First submitted
- 3 Jul 2019
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The results will be available without restriction
Publications
Dada T, Mittal D, Mohanty K, Faiq MA, Bhat MA, Yadav RK, Sihota R, Sidhu T, Velpandian T, Kalaivani M, Pandey RM, Gao Y, Sabel BA, Dada R. Mindfulness Meditation Reduces Intraocular Pressure, Lowers Stress Biomarkers and Modulates Gene Expression in Glaucoma: A Randomized Controlled Trial. J Glaucoma. 2018 Dec;27(12):1061-1067. doi: 10.1097/IJG.0000000000001088.
PubMed 30256277Sabel BA, Flammer J, Merabet LB. Residual vision activation and the brain-eye-vascular triad: Dysregulation, plasticity and restoration in low vision and blindness - a review. Restor Neurol Neurosci. 2018;36(6):767-791. doi: 10.3233/RNN-180880.
PubMed 30412515Zhou W, Sabel BA. Vascular dysregulation in glaucoma: retinal vasoconstriction and normal neurovascular coupling in altitudinal visual field defects. EPMA J. 2023 Feb 16;14(1):87-99. doi: 10.1007/s13167-023-00316-6. eCollection 2023 Mar.
PubMed 36866155
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alternative Home Training Possibilities for Glaucoma Patients
- ClinicalTrials.gov ID
- NCT04037384
- Acronym / sponsor ID
- EyeYoga / UMagdeburg
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of MagdeburgUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 30 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the trial is to investigate the possibilities of improving visual impairments with eye training exercises (eye-yoga) in a total of 40 patients with glaucoma who have not previously been treated within a similar training program. 20 patients will be instructed how to do eye yoga to be performed dails for 4 weeks (max 30 min/day). As a control group of 20 patients will be instructed to read for 30 min/day for 4 weeks.
The following outcome measures will be investigated: High Resolution Perimetry, Humphrey Perimetry, Visual Acuity Test, Contrast Sensitivity Test, Microsaccades measurements, Intraocular Pressure Measurement, Electroencephalogram (EEG), Blood Pressure and Pulse Measurement and Dynamic Vessel Analysis (DVA - the blood supply in the eye (especially vascular dysregulation) .
Furthermore, factors that could influence response variability and the effectiveness of treatment will be analysed: (i) the role of mental stress (or stress resilience) and (ii) the influence of personality traits and quality of life.
The study is intended to further validate this home training program (eye yoga) for the treatment of visual impairment in glaucoma.
Detailed description
The aim of eye yoga is to improve microsaccade impairments in patient with primary open angle glaucoma. We will study how this affects visual performance and the physiology of the eye and brain
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eye Yoga group | Active comparator | Behavioral: Passive ReadingEye yoga exercises |
| Reading Group | Placebo comparator | Behavioral: Eye yogaPassive reading |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- clinical diagnosis of glaucoma
- residual vision
- the duration of the disease must be at least 6 months old
- the visual field defect must be stable
Key exclusion criteria (10 listed)
- autoimmune diseases in the acute stage
- neurological and mental diseases
- diabetic retinopathy
- addictions
- hypertension (maximum 160/100 mmHg)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eye yogaEye yoga exercises at home given by a trained instructor | Behavioural | Reading Group |
| Passive ReadingPassive reading at home | Behavioural | Eye Yoga group |
Primary outcome
Visual field size determined by perimetry measurements
Time frame: 4 weeks
Changes of the visual field's size, evaluated by static perimetry and high resolution perimetry measurements
Microsaccade measurements
Time frame: 4 weeks
Changes in the deviation of eye movements when visual targets are followed, using a computerized test
2 secondary outcomes
Blood circulation in the eye
Time frame: 4 weeks
EEG connectivities
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Background: PubMed 30256277Dada T, Mittal D, Mohanty K, Faiq MA, Bhat MA, Yadav RK, Sihota R, Sidhu T, Velpandian T, Kalaivani M, Pandey RM, Gao Y, Sabel BA, Dada R. Mindfulness Meditation Reduces Intraocular Pressure, Lowers Stress Biomarkers and Modulates Gene Expression in Glaucoma: A Randomized Controlled Trial. J Glaucoma. 2018 Dec;27(12):1061-1067. doi: 10.1097/IJG.0000000000001088.
- Background: PubMed 30412515Sabel BA, Flammer J, Merabet LB. Residual vision activation and the brain-eye-vascular triad: Dysregulation, plasticity and restoration in low vision and blindness - a review. Restor Neurol Neurosci. 2018;36(6):767-791. doi: 10.3233/RNN-180880.
- Derived from this study: PubMed 36866155Zhou W, Sabel BA. Vascular dysregulation in glaucoma: retinal vasoconstriction and normal neurovascular coupling in altitudinal visual field defects. EPMA J. 2023 Feb 16;14(1):87-99. doi: 10.1007/s13167-023-00316-6. eCollection 2023 Mar.
- Individual participant dataSharing planned: Yes. The results will be available without restriction
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernhard A Sabel, PhD principal investigator
University of Magdeburg
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eye yoga and Passive Reading in people with Glaucoma and Eye Yoga, run by University of Magdeburg at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bernhard A Sabel, PhD (+491732540612, bernhard.sabel@med.ovgu.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual field size determined by perimetry measurements (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04037384, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021.