Assessment of Visual Sensitivity, Psychiatric Profile and Quality of Life Following Vestibular Schwannoma Surgery in Patients Prehabituated by Chemical Vestibular Ablation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 37
- Locations
- 2
- Primary Endpoint
- change of optokinetic nystagmus measurement
Study Overview
Brief Summary
The aim of this study is to assess effect of psychiatric profile on visual sensitivity and overall health status in patients who underwent surgery for vestibular schwannoma and were prehabituated by chemical vestibular ablation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •T3, T4 vestibular schwannoma
- •recorded growth of a tumour
- •hearing loss greater than 50% in PTA
Exclusion Criteria
- •T1 vestibular schwannomas
- •no growth progression
- •normal hearing
Arms & Interventions
ITG (intratympanic gentamicin) group
Patients who underwent prehabituation by gentamicin prior to surgery for vestibular schwannoma. They underwent intratympanic application of gentamicin and microsurgical removal of vest. schwannoma.
Intervention: intratympanic application of gentamicin (Procedure)
ITG (intratympanic gentamicin) group
Patients who underwent prehabituation by gentamicin prior to surgery for vestibular schwannoma. They underwent intratympanic application of gentamicin and microsurgical removal of vest. schwannoma.
Intervention: microsurgical removal of vestibular schwannoma (Procedure)
control group
patients without prehabituation before surgery. They underwent microsurgical removal of vest. schwannoma.
Intervention: microsurgical removal of vestibular schwannoma (Procedure)
Outcomes
Primary Outcomes
change of optokinetic nystagmus measurement
Time Frame: change of the gain of optokinetic nystagmus among 3 time points is measured: before intervention, 1 week after intervention, 3 months after intervention
During electronystagmography gain of optokinetic nystagmus is measured before and after the intervention
Secondary Outcomes
No secondary outcomes reported
Investigators
Balatkova Zuzana
Zuzana Balatkova, M.D., Principal Investigator, Department of otorhinolaryngology and head and neck surgery,1st faculty of medicine Charles university and University hospital Motol, Prague, Head: Prof. Jan Plzak, M.D., Ph.D.
Charles University, Czech Republic