A Mechanical Device for Blepharospasm

NCT03269123 | Completed

• 1 other identifier: 5663
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Sensory trick; Geste Antagoniste

Outcome Measures

Primary Outcomes (1)

• The study's objective and subjective responses for the use of the device is measured with the CDQ-24 questionnaire and a questionnaire specific to the the device

  Outcome measures will be taken from the CDQ-24 assessment carried out before and after using the pressure device demonstrating improved quality of life.The questionnaire specific to the device addresses issues like wearing time, discomfort, suggestions and feedback .

  2-3 week trial period

Secondary Outcomes (1)

• The proportion of patients demonstrating the "Geste Antagoniste" phenomenon.

  2-3 week trial period

Study Arms (1)

A device to relieve Blepharospasm

OTHER

The pressure device known as Pressop1 is the intervention which is attached to the spectacles and worn for 2 weeks prior to retreatment with Botulinum Toxin injections to assess its effectiveness in controlling eyelid spasms.

Device: Pressop 1

Interventions

Pressop 1 DEVICE

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

A device to relieve Blepharospasm

Eligibility Criteria

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

You may qualify if:

• Any adult patient with Blepharospasm of sufficient severity to necessitate repeated Botulinum injections can be included in the study.
• It is not essential for participants to be spectacle wearers (having a refractive error) as prescription free (zero power) spectacles can be provided for the purposes of being able to trial the device .
• The participants may or may not be currently having Botulinum Toxin injections. Some of these patients will be known to use the "Geste Antagoniste" phenomenon. Patients who may not know of this potential therapeutic effect will also be invited to trial the device.

You may not qualify if:

• Inability to wear spectacles due to any reason (as the device has to be mounted on the spectacle frame).
• Patients who have spasms and twitches of the eyes caused by a different pathology e.g. Hemi facial Spasm, Parkinson's disease will also be excluded from this trial.

Sponsors & Collaborators

• Oxford University Hospitals NHS Trust: lead
• The Dystonia Society of the United Kingdom: collaborator
• Globsource UK: collaborator
• Statsconsultancy Ltd, Amersham, Buckinghamshire,UK: collaborator

MeSH Terms

Conditions

Blepharospasm

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Study Officials

• John S Elston, MD FRCS OPTH

  Oxford University Hospitals NHS Trust

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Clinical trial with a single arm

Study Record Dates

• First Submitted: August 16, 2017
• First Posted: August 31, 2017
• Study Start: March 2, 2010
• Primary Completion: August 8, 2011
• Study Completion: August 8, 2011
• Last Updated: August 31, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share