Training of Eye Movements in Glaucoma

NCT04037384 | Unknown

• 1 other identifier: UMagdeburg
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Glaucoma; Eye Yoga

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Blood circulation in the eye

  4 weeks

• EEG connectivities

  4 weeks

Study Arms (2)

Eye Yoga group

ACTIVE COMPARATOR

Eye yoga exercises

Behavioral: Passive Reading

Reading Group

PLACEBO COMPARATOR

Passive reading

Behavioral: Eye yoga

Interventions

Eye yoga BEHAVIORAL

Eye yoga exercises at home given by a trained instructor

Reading Group

Passive Reading BEHAVIORAL

Passive reading at home

Eye Yoga group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Magdeburg: lead

Study Sites (2)

Inst. of Medical Psychology, Univ. of Magdeburg

Magdeburg, 39120, Germany

RECRUITING

Institute of Medical Psychology

Magdeburg, 39120, Germany

RECRUITING

Related Publications (3)

• 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.

  PMID: 30256277 BACKGROUND

• 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.

  PMID: 30412515 BACKGROUND

• Zhou 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.

  PMID: 36866155 DERIVED

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Bernhard A Sabel, PhD

  University of Magdeburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bernhard A Sabel, PhD

CONTACT

+491732540612; bernhard.sabel@med.ovgu.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Institute, Professor

Study Record Dates

• First Submitted: July 3, 2019
• First Posted: July 30, 2019
• Study Start: August 1, 2019
• Primary Completion: December 31, 2022
• Study Completion: August 1, 2023
• Last Updated: February 9, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After the results are published, unlimited duration
• Access Criteria: Contact to the principal investigator

Locations

DE (2)