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CompletedNCT03390803Updated Jan 4, 2018

Effect of Hemifacial Spasm on Intraocular Pressure Measurement

An observational study in Hemifacial Spasm and Intraocular Pressure, sponsored by Medipol University. Completed. Open to participants aged 40 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-04.

Sponsored by Medipol University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
49
Ages
40 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hemifacial Spasm
  • Intraocular Pressure
03

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
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.

Inclusion criteria

  • patients with hemifacial spasm

Exclusion criteria

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.
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
49 participants (actual)
Patient registry
No

Groups and cohorts

  • patients with hemifacial spasm

    Other: effect of hemifacial spasm on intraocular pressure

  • healthy control subjects

    Other: effect of hemifacial spasm on intraocular pressure

Interventions

  • Othereffect of hemifacial spasm on intraocular pressure

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

05

What researchers measure

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.

    Time frame: 2 week

06

Study locations

No study locations are listed for this record.

07

References and documents

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 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03390803
Lead sponsor
Medipol University
Responsible party
Funda Dikkaya (Medical Doctor, Medipol University) — Principal investigator
First posted
Jan 4, 2018
Start date
Jan 1, 2017
Primary completion
Dec 20, 2017
Completion
Dec 20, 2017
Last update
Jan 4, 2018

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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