Effect of Hemifacial Spasm on Intraocular Pressure Measurement

NCT03390803 | Completed DMC

• 1 other identifier: 02-115621
• Study Type: observational
• Target: 49
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hemifacial Spasm; Intraocular Pressure

Outcome Measures

Primary Outcomes (1)

• 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.

  2 week

Study Arms (2)

patients with hemifacial spasm

Other: effect of hemifacial spasm on intraocular pressure

healthy control subjects

Other: effect of hemifacial spasm on intraocular pressure

Interventions

effect of hemifacial spasm on intraocular pressure OTHER

To evaluate the effect of Hemifacial spasm on Intraocular pressure measurement.

healthy control subjects; patients with hemifacial spasm

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• patients with hemifacial spasm

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medipol University: lead

Related Publications (1)

• 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.

  PMID: 29545951 DERIVED

MeSH Terms

Conditions

Hemifacial Spasm

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Spasm; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: December 26, 2017
• First Posted: January 4, 2018
• Study Start: January 1, 2017
• Primary Completion: December 20, 2017
• Study Completion: December 20, 2017
• Last Updated: January 4, 2018

Record last verified: 2018-01