Training of Eye Movements in Glaucoma

Glaucoma Clinical Trial

— EyeYoga  

Official title:

Alternative Home Training Possibilities for Glaucoma Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04037384
• Other study ID #: UMagdeburg
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: August 1, 2023

Study information

• Verified date: February 2021
• Source: University of Magdeburg
• Contact: Bernhard A Sabel, PhD
• Phone: +491732540612
• Email: bernhard.sabel[@]med.ovgu.de
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 1, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Eye Yoga
• Glaucoma

Intervention

Behavioral:
• Eye yoga
Eye yoga exercises at home given by a trained instructor
• Passive Reading
Passive reading at home

Locations

Country	Name	City	State
Germany	Inst. of Medical Psychology, Univ. of Magdeburg	Magdeburg
Germany	Institute of Medical Psychology	Magdeburg

Sponsors (1)

Lead Sponsor	Collaborator
University of Magdeburg

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Microsaccade measurements	Changes in the deviation of eye movements when visual targets are followed, using a computerized test	4 weeks
Secondary	Blood circulation in the eye	Changes of the diameter of blood vessels in the eye, measured by vessel analysis	4 weeks
Secondary	EEG connectivities	Changes in alpha power using EEG recording (128 channels)	4 weeks