Hemifacial SpasmNCT03390803
Effect of Hemifacial Spasm on Intraocular Pressure Measurement
An observational study of Hemifacial Spasm and Intraocular Pressure, run by Medipol University.
Trial summary
Twenty-four consecutive patients with Hemifacial spasm and 25 age and gender-matched randomly selected eyes of healthy volunteers underwent corneal pachymetry and intraocular pressure measurements using Goldmann Applanation Tonometer and non-contact tonometer. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemifacial Spasm, Intraocular Pressure
- What is being tested?
- effect of hemifacial spasm on intraocular pressure
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 20 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Twenty-four consecutive patients with Hemifacial spasm (study group) and twenty-five age-matched and gender-matched healthy volunteers (control group) will be prospectively included in the study. Intraocular pressure measurements will be performed before and 2 weeks after Botox injections in patients with HFS (involved and uninvolved eyes of HFS both) and in healthy volunteers without Botox injections.
Who may be able to join
- patients with hemifacial spasm
Who cannot join
- Subjects will be excluded if they have allergies to botulinum toxin or any component of the drug, previous eyelid, refractive or intraocular surgery, any abnormality preventing reliable tonometry in either eye, strabismus, contact lens wear, pregnancy, glaucoma, ocular hypertension and patients using agents that could interfere with neuromuscular transmission.
About this study
Twenty-four consecutive patients with Hemifacial spasm and 25 age and gender-matched randomly selected eyes of healthy volunteers underwent corneal pachymetry and intraocular pressure measurements using Goldmann Applanation Tonometer and non-contact tonometer. An interval of 15 minutes was maintained between Goldmann Applanation Tonometer and non-contact tonometer measurements. Intraocular pressure measurements were performed before (during hemifacial spasm) and 2 weeks after Botox injections in Hemifacial spasm patients and in healthy volunteers without Botox injections. All the measurements with Goldmann Applanation Tonometer were carried out by a single physician while those with the non-contact tonometer were done by another physician who was masked to the results of the Goldmann Applanation Tonometer. All measurements were taken between 10:00 and 11:00 a.m.
- Conditions
- Hemifacial Spasm, Intraocular Pressure
- Being tested
- effect of hemifacial spasm on intraocular pressure
- Medical subject headings
- Hemifacial Spasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
effect of hemifacial spasm on intraocular pressureOther
To evaluate the effect of Hemifacial spasm on Intraocular pressure measurement.
| Study group | Role | What they receive |
|---|---|---|
| patients with hemifacial spasm | Not described Receives: Other: effect of hemifacial spasm on intraocular pressure | |
| healthy control subjects | Not described Receives: Other: effect of hemifacial spasm on intraocular pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Hemifacial Spasm on Intraocular Pressure Measurement Change
intraocular pressure measurements will be performed before and 2 weeks after Botox injections in patients with Hemifacial spasm (involved and uninvolved eyes of Hemifacial spasm both) and in healthy volunteers without Botox injections. The change between measurements will be evaluated.
Measured: 2 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2018
- Study start1 Jan 2017
- Primary completion20 Dec 2017
- Study completion20 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemifacial SpasmStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Funda Dikkaya, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03390803
- Sponsor's protocol ID
- 02-115621
- Status last verified
- Jan 2018
- First submitted
- 26 Dec 2017
- Last updated
- 4 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cicik E, Yildirim R, Arici C, Dikkaya F, Arslan OS. Effect of Hemifacial Spasm on Intraocular Pressure Measurement. J Ophthalmol. 2018 Feb 6;2018:3621215. doi: 10.1155/2018/3621215. eCollection 2018.
PubMed 29545951
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hemifacial Spasm on Intraocular Pressure Measurement
- ClinicalTrials.gov ID
- NCT03390803
- Acronym / sponsor ID
- 02-115621
- Conditions
- Hemifacial Spasm, Intraocular Pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 4 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Twenty-four consecutive patients with Hemifacial spasm and 25 age and gender-matched randomly selected eyes of healthy volunteers underwent corneal pachymetry and intraocular pressure measurements using Goldmann Applanation Tonometer and non-contact tonometer. An interval of 15 minutes was maintained between Goldmann Applanation Tonometer and non-contact tonometer measurements. Intraocular pressure measurements were performed before (during hemifacial spasm) and 2 weeks after Botox injections in Hemifacial spasm patients and in healthy volunteers without Botox injections. All the measurements with Goldmann Applanation Tonometer were carried out by a single physician while those with the non-contact tonometer were done by another physician who was masked to the results of the Goldmann Applanation Tonometer. All measurements were taken between 10:00 and 11:00 a.m.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with hemifacial spasm | – | Other: effect of hemifacial spasm on intraocular pressure |
| healthy control subjects | – | Other: effect of hemifacial spasm on intraocular pressure |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Twenty-four consecutive patients with Hemifacial spasm (study group) and twenty-five age-matched and gender-matched healthy volunteers (control group) will be prospectively included in the study. Intraocular pressure measurements will be performed before and 2 weeks after Botox injections in patients with HFS (involved and uninvolved eyes of HFS both) and in healthy volunteers without Botox injections.
Key inclusion criteria (1 listed)
- patients with hemifacial spasm
Key exclusion criteria (1 listed)
- Subjects will be excluded if they have allergies to botulinum toxin or any component of the drug, previous eyelid, refractive or intraocular surgery, any abnormality preventing reliable tonometry in either eye, strabismus, contact lens wear, pregnancy, glaucoma, ocular hypertension and patients using agents that could interfere with neuromuscular transmission.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| effect of hemifacial spasm on intraocular pressureTo evaluate the effect of Hemifacial spasm on Intraocular pressure measurement. | Other | healthy control subjects, patients with hemifacial spasm |
Primary outcome
Effect of Hemifacial Spasm on Intraocular Pressure Measurement Change
Time frame: 2 week
intraocular pressure measurements will be performed before and 2 weeks after Botox injections in patients with Hemifacial spasm (involved and uninvolved eyes of Hemifacial spasm both) and in healthy volunteers without Botox injections. The change between measurements will be evaluated.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2018.
- Derived from this study: PubMed 29545951Cicik E, Yildirim R, Arici C, Dikkaya F, Arslan OS. Effect of Hemifacial Spasm on Intraocular Pressure Measurement. J Ophthalmol. 2018 Feb 6;2018:3621215. doi: 10.1155/2018/3621215. eCollection 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemifacial Spasm and Intraocular Pressure, run by Medipol University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Hemifacial Spasm on Intraocular Pressure Measurement Change (time frame: 2 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03390803, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2018.