Status:
COMPLETED
Clinical and Genetic Testing of Patients With Usher Syndrome
Lead Sponsor:
Sensor Technology for Deafblind
Collaborating Sponsors:
Burnasyan Federal Medical Biophysical Center
Scientific and Clinical Center for Otorhinolaryngology of FMBA of Russia
Conditions:
Usher Syndrome
Congenital Deafness
Eligibility:
All Genders
18-65 years
Brief Summary
This study is aimed to characterize Russian population of Usher patients.
Detailed Description
This study is aimed to characterize Russian population of Usher patients. Tasks: Stage 1. Formation of the primary cohort of patients. Patients pre-recruiting will be performed based on Deaf-Blind S...
Eligibility Criteria
Inclusion
- Patient fulfill the clinical characteristics for Usher syndrome type I, II or III as defined by the Usher syndrome consortium
- According to the results of audiometry, hearing loss is moderate or severe (level of acoustic threshold of audibility is 41 decibel and higher).
- Results of perimetry for each eye show narrowing for 15 degrees or more.
- Patient is familiar with Participant information sheet
- Patient signed informed consent form
- Non-inclusion Criteria:
- Participation in other clinical trials (or administration of investigational drugs) during 3 months prior inclusion
- Any conditions limiting compliance (dementia, neuropsychiatric disease, drug and alcohol abuse etc.)
- Medical history of traumatic injury of eyes, barotrauma, concussion, craniocerebral trauma, cerebrovascular accident
Exclusion
- Patient's refusal from the further participation in the trial
- Decompensated diabetes mellitus
- Severe coronary artery disease
- Chronic infectious disease
- Patients with malignant tumors including postoperative period, patients receiving chemotherapy and/or radiotherapy
Key Trial Info
Start Date :
May 17 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2018
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03319524
Start Date
May 17 2017
End Date
June 1 2018
Last Update
April 3 2019
Active Locations (6)
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1
Federal State Budgetary Institution "Research Center for Medical Genetics"
Moscow, Russia, 115478
2
Deaf-Blind Support Foundation "Con-nection"
Moscow, Russia, 117593
3
State Research Center Burnasyan Federal Medical Biophysical Center Federal Medical-Biological Agency
Moscow, Russia, 123098
4
Scientific and Clinical Center for Otorhinolaryngology of FMBA of Russia
Moscow, Russia, 123182