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A Mechanical Device for Blepharospasm

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ClinicalTrials.gov Identifier: NCT03269123
Recruitment Status : Completed
First Posted : August 31, 2017
Last Update Posted : August 31, 2017
Sponsor:
Collaborators:
The Dystonia Society of the United Kingdom
Globsource UK
Statsconsultancy Ltd, Amersham, Buckinghamshire,UK
Information provided by (Responsible Party):
Alexina Fantato, Oxford University Hospitals NHS Trust

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.


Condition or disease Intervention/treatment Phase
Blepharospasm Device: Pressop 1 Not Applicable

Detailed Description:

Idiopathic blepharospasm is a rare chronic neuro-ophthalmic disorder that causes substantial visual handicap & compromises quality of life. It affects adults, women more than men, usually beginning in the 5th or 6th decade and consists of repeated forceful bilateral spasms of eye closure with photophobia and ocular surface discomfort. In up to a third of cases there are synchronous mid and / or lower facial spasms and the spectrum of disorder extends to cranial dystonia involving jaw & neck muscle spasms (e.g. antecollis or retrocollis). Practical visual function is variably affected but most patients will have to stop driving, many cannot work, manage the house or even leave the house unaccompanied. Leisure activities such as reading & watching television are compromised or impossible, and secondary mood dysphoria and depression are common.

In some cases, patients have discovered that applying focal finger pressure, usually to the temple, relieves or even abolishes the spasms for the duration of the application. It is, however, difficult for the patient to sustain the finger pressure and impossible to apply it during activities when eyesight is important e.g. driving, typing or other bimanual tasks. The phenomenon can be regarded as the equivalent of the sensory trick (ST or geste antagonistique) seen in some cases of spasmodic torticollis whereby finger tip pressure on the chin prevents or reduces the muscle spasms in the neck and allows the head to be held straight.

In this study, the Investigators explored the hypothesis that the benefit of the finger-tip pressure sensory trick could be replicated by a spring-loaded, spectacle mounted device applying focal pressure to the temple. Following preliminary design trials, the investigators commissioned a manufacturer to develop a light easily handled pressure device that could be fixed to the frame of most spectacles. The "Pressop" device fulfils these criteria and was adopted for the trial.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Clinical trial with a single arm
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Trial of a Mechanical Device for the Treatment of Blepharospasm
Actual Study Start Date : March 2, 2010
Actual Primary Completion Date : August 8, 2011
Actual Study Completion Date : August 8, 2011


Arm Intervention/treatment
A device to relieve Blepharospasm
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
A pressure device attached to the spectacles which mimics a sensory trick (geste Antagoniste)




Primary Outcome Measures :
  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 [ Time Frame: 2-3 week trial period ]
    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 .


Secondary Outcome Measures :
  1. The proportion of patients demonstrating the "Geste Antagoniste" phenomenon. [ Time Frame: 2-3 week trial period ]
    This proportion will be presented, along with its 95% confidence interval



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03269123


Sponsors and Collaborators
Oxford University Hospitals NHS Trust
The Dystonia Society of the United Kingdom
Globsource UK
Statsconsultancy Ltd, Amersham, Buckinghamshire,UK
Investigators
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Study Director: John S Elston, MD FRCS OPTH Oxford University Hospitals NHS Trust

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Responsible Party: Alexina Fantato, Principal Investigator, Oxford University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT03269123     History of Changes
Other Study ID Numbers: 5663
First Posted: August 31, 2017    Key Record Dates
Last Update Posted: August 31, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The study findings will be published in the appropriate medical journal

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alexina Fantato, Oxford University Hospitals NHS Trust:
Sensory trick
Geste Antagoniste

Additional relevant MeSH terms:
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Blepharospasm
Eyelid Diseases
Eye Diseases