A Mechanical Device for Blepharospasm
Primary Purpose
Blepharospasm
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pressop 1
Sponsored by
About this trial
This is an interventional treatment trial for Blepharospasm focused on measuring Sensory trick, Geste Antagoniste
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
A device to relieve Blepharospasm
Arm Description
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.
Outcomes
Primary Outcome Measures
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 .
Secondary Outcome Measures
The proportion of patients demonstrating the "Geste Antagoniste" phenomenon.
This proportion will be presented, along with its 95% confidence interval
Full Information
NCT ID
NCT03269123
First Posted
August 16, 2017
Last Updated
August 29, 2017
Sponsor
Oxford University Hospitals NHS Trust
Collaborators
The Dystonia Society of the United Kingdom, Globsource UK, Statsconsultancy Ltd, Amersham, Buckinghamshire,UK
1. Study Identification
Unique Protocol Identification Number
NCT03269123
Brief Title
A Mechanical Device for Blepharospasm
Official Title
Clinical Trial of a Mechanical Device for the Treatment of Blepharospasm
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
March 2, 2010 (Actual)
Primary Completion Date
August 8, 2011 (Actual)
Study Completion Date
August 8, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oxford University Hospitals NHS Trust
Collaborators
The Dystonia Society of the United Kingdom, Globsource UK, Statsconsultancy Ltd, Amersham, Buckinghamshire,UK
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blepharospasm
Keywords
Sensory trick, Geste Antagoniste
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Clinical trial with a single arm
Masking
None (Open Label)
Allocation
N/A
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A device to relieve Blepharospasm
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Pressop 1
Intervention Description
A pressure device attached to the spectacles which mimics a sensory trick (geste Antagoniste)
Primary Outcome Measure Information:
Title
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
Description
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 .
Time Frame
2-3 week trial period
Secondary Outcome Measure Information:
Title
The proportion of patients demonstrating the "Geste Antagoniste" phenomenon.
Description
This proportion will be presented, along with its 95% confidence interval
Time Frame
2-3 week trial period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John S Elston, MD FRCS OPTH
Organizational Affiliation
Oxford University Hospitals NHS Trust
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The study findings will be published in the appropriate medical journal
Learn more about this trial
A Mechanical Device for Blepharospasm
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