Training of Eye Movements in Glaucoma

NCT ID: NCT04037384

Last Updated: 2021-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2023-08-01

Brief Summary

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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

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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

Conditions

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Glaucoma Eye Yoga

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Eye Yoga group

Eye yoga exercises

Group Type ACTIVE_COMPARATOR

Passive Reading

Intervention Type BEHAVIORAL

Passive reading at home

Reading Group

Passive reading

Group Type PLACEBO_COMPARATOR

Eye yoga

Intervention Type BEHAVIORAL

Eye yoga exercises at home given by a trained instructor

Interventions

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Eye yoga

Eye yoga exercises at home given by a trained instructor

Intervention Type BEHAVIORAL

Passive Reading

Passive reading at home

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Magdeburg

OTHER

Sponsor Role lead

Responsible Party

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Bernhard A. Sabel

Head of Institute, Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bernhard A Sabel, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Magdeburg

Locations

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Inst. of Medical Psychology, Univ. of Magdeburg

Magdeburg, , Germany

Site Status RECRUITING

Institute of Medical Psychology

Magdeburg, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Bernhard A Sabel, PhD

Role: CONTACT

+491732540612

Facility Contacts

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Bernhard Sabel, Prof. Dr.

Role: primary

0049 (0)3916721 ext. 800

Bernhard A Sabel, Prof.

Role: primary

+ 49 391 67 21 800

Sylvia Prilloff, PhD

Role: backup

+ 49 391 67 21 807

References

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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.

Reference Type BACKGROUND
PMID: 30256277 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30412515 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36866155 (View on PubMed)

Other Identifiers

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UMagdeburg

Identifier Type: -

Identifier Source: org_study_id

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