An observational study in Usher Syndrome, Congenital Deafness and Retinitis Pigmentosa, sponsored by Sensor Technology for Deafblind. Completed at 6 sites in Russian Federation. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-04-03.
Sponsored by Sensor Technology for Deafblind · Observational
This study is aimed to characterize Russian population of Usher patients.
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 Support Foundation "Con-nection" patient database analysis. Patients with clinically confirmed Usher syndrome will be evaluated according to available data of the clinical examination.
Stage 2. Clinical examination of patients.
Each patient will undergo the following diagnostic procedures according to the unified protocol:
Medical record will be developed and maintained for each patient consisting results of extended clinical examination.
Stage 3. Genetic study of patients. All enrolled patients will undergo single 4 ml peripheral venous blood sampling. DNA will be extracted from leucocytes. DNA samples will be analyzed and placed for long-term storage in liquid nitrogen. Statistical and bioinformatic analysis of detected genetic mutations in the study cohort will be performed.
33 studies on the registry are indexed under Usher Syndromes; 13 are open to participants now.
This study's enrollment of 28 is below the median of 165 across 14 observational studies indexed under Usher Syndromes.
Browse Usher Syndromes studies →Sensor Technology for Deafblind is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
It is assumed that at least 28 patients of the Russian population of men and women aged 18 to 65 years, with verified diagnosis of Usher syndrome (type I, II or III as defined by the Usher syndrome consortium), will take part in this research study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Non-inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Changes in visual acuity
Measured by visometry
Time frame: Up to 4 weeks
Changes in structures of fundus of the eye-1
Measured by ophthalmoscopy
Time frame: Up to 4 weeks
Changes in structures of fundus of the eye-2
Measured by optical coherence tomography
Time frame: Up to 4 weeks
Changes in visual field
Measured by perimetry
Time frame: Up to 4 weeks
Changes in retinal ganglion cell dysfunction
Measured by electroretinography
Time frame: Up to 4 weeks
Changes in brain visual cortex neural pathways
Measured by visually evoked potentials
Time frame: Up to 4 weeks
Changes in optical refraction
Measured by refractometry
Time frame: Up to 4 weeks
Changes in intraocular pressure
Measured by pneumotonometry
Time frame: Up to 4 weeks
Changes in the lens, cornea, anterior segment of the eye
Measured by biomicroscopy
Time frame: Up to 4 weeks
Changes in hearing-1
Measured by tonal audiometry
Time frame: Up to 4 weeks
Changes in hearing-2
Measured by electronic audiometry (ASSR test)
Time frame: Up to 4 weeks
Changes in efficient sound transmission in the middle ear
Measured by acoustic impedance measurement
Time frame: Up to 4 weeks
Changes in vestibular functions
Measured by vestibulometry
Time frame: Up to 4 weeks
Changes in vestibular reactions
Measured by electronystagmography
Time frame: Up to 4 weeks
Plan to share: Undecided
Ran from May 2017 to primary completion in Apr 2018, 10 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Sensor Technology for Deafblind