Effect of Hemifacial Spasm on Intraocular Pressure Measurement

• Sponsor: Medipol University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03390803
• Collaborator: (none)
• Enrollment: 49
• Actual Duration (Months): 11.6

Study Details

Study Description

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	Phase
Hemifacial Spasm; Intraocular Pressure	Other: effect of hemifacial spasm on intraocular pressure

Study Design

• 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: Jan 1, 2017
• Actual Primary Completion Date: Dec 20, 2017
• Actual Study Completion Date: Dec 20, 2017

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Effect of Hemifacial Spasm on Intraocular Pressure Measurement Change [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Medipol University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Funda Dikkaya, Medical Doctor, Medipol University
• ClinicalTrials.gov Identifier: NCT03390803
• Other Study ID Numbers: 02-115621
• First Posted: Jan 4, 2018
• Last Update Posted: Jan 4, 2018
• Last Verified: Jan 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hemifacial Spasm; Spasm

Study Results

No Results Posted as of Jan 4, 2018