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Effect of Hemifacial Spasm on Intraocular Pressure Measurement

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ClinicalTrials.gov Identifier: NCT03390803
Recruitment Status : Completed
First Posted : January 4, 2018
Last Update Posted : January 4, 2018
Sponsor:
Information provided by (Responsible Party):
Funda Dikkaya, Medipol University

Brief 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. 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.

Condition or disease Intervention/treatment
Hemifacial Spasm Intraocular Pressure Other: effect of hemifacial spasm on intraocular pressure

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Study Type : Observational
Actual Enrollment : 49 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Effect of Hemifacial Spasm on Intraocular Pressure Measurement
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : December 20, 2017
Actual Study Completion Date : December 20, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Muscle Cramps

Group/Cohort Intervention/treatment
patients with hemifacial spasm Other: effect of hemifacial spasm on intraocular pressure
To evaluate the effect of Hemifacial spasm on Intraocular pressure measurement.

healthy control subjects Other: effect of hemifacial spasm on intraocular pressure
To evaluate the effect of Hemifacial spasm on Intraocular pressure measurement.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  • patients with hemifacial spasm

Exclusion Criteria:

  • 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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Funda Dikkaya, Medical Doctor, Medipol University
ClinicalTrials.gov Identifier: NCT03390803    
Other Study ID Numbers: 02-115621
First Posted: January 4, 2018    Key Record Dates
Last Update Posted: January 4, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemifacial Spasm
Spasm
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mouth Diseases
Stomatognathic Diseases