Training of Eye Movements in Glaucoma (EyeYoga)

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) .

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.

Study Overview

• Status: Recruiting
• Conditions: Glaucoma; Eye Yoga
• Intervention / Treatment: Behavioral: Passive Reading; Behavioral: Eye yoga

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bernhard A Sabel, PhD; Phone Number: +491732540612; Email: bernhard.sabel@med.ovgu.de

Study Locations

• Germany
  • Magdeburg, Germany, 39120
    • Recruiting
    • Inst. of Medical Psychology, Univ. of Magdeburg
    • Contact: Bernhard Sabel, Prof. Dr.; Phone Number: 800 0049 (0)3916721; Email: bernhard.sabel@med.ovgu.de
    • Principal Investigator: Bernhard Sabel, Prof. Dr.
  • Magdeburg, Germany, 39120
    • Recruiting
    • Institute of Medical Psychology
    • Contact: Bernhard A Sabel, Prof.; Phone Number: + 49 391 67 21 800; Email: bernhard.sabel@med.ovgu.de
    • Contact: Sylvia Prilloff, PhD; Phone Number: + 49 391 67 21 807; Email: sylvia.prilloff@med.ovgu.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Eye Yoga group; Eye yoga exercises	Behavioral: Passive Reading; Passive reading at home
Placebo Comparator: Reading Group; Passive reading	Behavioral: Eye yoga; Eye yoga exercises at home given by a trained instructor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual field size determined by perimetry measurements	Changes of the visual field's size, evaluated by static perimetry and high resolution perimetry measurements	4 weeks
Microsaccade measurements	Changes in the deviation of eye movements when visual targets are followed, using a computerized test	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood circulation in the eye	Changes of the diameter of blood vessels in the eye, measured by vessel analysis	4 weeks
EEG connectivities	Changes in alpha power using EEG recording (128 channels)	4 weeks

Collaborators and Investigators

• Sponsor: University of Magdeburg
• Investigators: Principal Investigator: Bernhard A Sabel, PhD, University of Magdeburg

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: July 3, 2019
• First Submitted That Met QC Criteria: July 29, 2019
• First Posted (Actual): July 30, 2019

Study Record Updates

• Last Update Posted (Actual): February 9, 2021
• Last Update Submitted That Met QC Criteria: February 4, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: UMagdeburg

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No