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A Mechanical Device for Blepharospasm

NCT03269123 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2017-08-31

No results posted yet for this study

Summary

Idiopathic blepharospasm (IB) is a rare but well characterised adult onset focal dystonia that may cause severe visual disability. The most effective treatment is with periodic injections of botulinum toxin into the pre-tarsal and / or pre-septal orbicularis oculi muscles bilaterally. However, even with treatment, practical visual function often remains compromised.

A subset of IB sufferers find that eye opening improves with focal unilateral digital pressure usually on a specific point on the temple. The Investigators have developed a spectacle mounted spring-loaded prosthesis (the "Pressop" device) to apply continuous individually localised focal pressure on the temple to mimic the effect of finger pressure.

The Investigators recommended a trial of this simple safe device in those IB patients who report improvement in eye opening with focal digital temple pressure.

Conditions

  • Blepharospasm

Interventions

DEVICE

Pressop 1

A pressure device attached to the spectacles which mimics a sensory trick (geste Antagoniste)

Sponsors & Collaborators

  • The Dystonia Society of the United Kingdom

    collaborator UNKNOWN

  • Globsource UK

    collaborator UNKNOWN

  • Statsconsultancy Ltd, Amersham, Buckinghamshire,UK

    collaborator UNKNOWN

  • Oxford University Hospitals NHS Trust

    lead OTHER

Principal Investigators

  • John S Elston, MD FRCS OPTH · Oxford University Hospitals NHS Trust

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-02
Primary Completion
2011-08-08
Completion
2011-08-08

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03269123 on ClinicalTrials.gov