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NCT03390803 Clinical Trial

Effect of Hemifacial Spasm on Intraocular Pressure Measurement

Intraocular Pressure Clinical Trial

Official title:
Effect of Hemifacial Spasm on Intraocular Pressure Measurement

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03390803
Other study ID # 02-115621
Secondary ID
Status Completed
Phase N/A
First received December 26, 2017
Last updated January 3, 2018
Start date January 1, 2017
Est. completion date December 20, 2017

Study information
Verified date January 2018
Source Medipol University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.

Recruitment information / eligibility
Status Completed
Enrollment 49
Est. completion date December 20, 2017
Est. primary completion date December 20, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 75 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Medipol University

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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