Training of Eye Movements in Glaucoma (EyeYoga)
Primary Purpose
Glaucoma, Eye Yoga
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Eye yoga
Passive Reading
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- autoimmune diseases in the acute stage
- neurological and mental diseases
- diabetic retinopathy
- addictions
- hypertension (maximum 160/100 mmHg)
- retinitis pigmentosa-
- pathological nystagmus
- non-distant tumors or recurrent tumors
- photosensitivity
- pregnancy
Sites / Locations
- Inst. of Medical Psychology, Univ. of MagdeburgRecruiting
- Institute of Medical PsychologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Eye Yoga group
Reading Group
Arm Description
Eye yoga exercises
Passive reading
Outcomes
Primary Outcome Measures
Visual field size determined by perimetry measurements
Changes of the visual field's size, evaluated by static perimetry and high resolution perimetry measurements
Microsaccade measurements
Changes in the deviation of eye movements when visual targets are followed, using a computerized test
Secondary Outcome Measures
Blood circulation in the eye
Changes of the diameter of blood vessels in the eye, measured by vessel analysis
EEG connectivities
Changes in alpha power using EEG recording (128 channels)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04037384
Brief Title
Training of Eye Movements in Glaucoma
Acronym
EyeYoga
Official Title
Alternative Home Training Possibilities for Glaucoma Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Magdeburg
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Eye Yoga
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Eye Yoga group
Arm Type
Active Comparator
Arm Description
Eye yoga exercises
Arm Title
Reading Group
Arm Type
Placebo Comparator
Arm Description
Passive reading
Intervention Type
Behavioral
Intervention Name(s)
Eye yoga
Intervention Description
Eye yoga exercises at home given by a trained instructor
Intervention Type
Behavioral
Intervention Name(s)
Passive Reading
Intervention Description
Passive reading at home
Primary Outcome Measure Information:
Title
Visual field size determined by perimetry measurements
Description
Changes of the visual field's size, evaluated by static perimetry and high resolution perimetry measurements
Time Frame
4 weeks
Title
Microsaccade measurements
Description
Changes in the deviation of eye movements when visual targets are followed, using a computerized test
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Blood circulation in the eye
Description
Changes of the diameter of blood vessels in the eye, measured by vessel analysis
Time Frame
4 weeks
Title
EEG connectivities
Description
Changes in alpha power using EEG recording (128 channels)
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
autoimmune diseases in the acute stage
neurological and mental diseases
diabetic retinopathy
addictions
hypertension (maximum 160/100 mmHg)
retinitis pigmentosa-
pathological nystagmus
non-distant tumors or recurrent tumors
photosensitivity
pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bernhard A Sabel, PhD
Phone
+491732540612
Email
bernhard.sabel@med.ovgu.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernhard A Sabel, PhD
Organizational Affiliation
University of Magdeburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inst. of Medical Psychology, Univ. of Magdeburg
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernhard Sabel, Prof. Dr.
Phone
0049 (0)3916721
Ext
800
Email
bernhard.sabel@med.ovgu.de
First Name & Middle Initial & Last Name & Degree
Bernhard Sabel, Prof. Dr.
Facility Name
Institute of Medical Psychology
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernhard A Sabel, Prof.
Phone
+ 49 391 67 21 800
Email
bernhard.sabel@med.ovgu.de
First Name & Middle Initial & Last Name & Degree
Sylvia Prilloff, PhD
Phone
+ 49 391 67 21 807
Email
sylvia.prilloff@med.ovgu.de
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The results will be available without restriction
IPD Sharing Time Frame
After the results are published, unlimited duration
IPD Sharing Access Criteria
Contact to the principal investigator
Citations:
PubMed Identifier
30256277
Citation
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.
Results Reference
background
PubMed Identifier
30412515
Citation
Sabel 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.
Results Reference
background
Learn more about this trial
Training of Eye Movements in Glaucoma
We'll reach out to this number within 24 hrs