Retinitis Pigmentosa SyndromicNCT00106743
Natural History and Genetic Studies of Usher Syndrome
An observational study of Retinitis Pigmentosa Syndromic and Congenital Deafness, run by National Eye Institute (NEI) at 2 sites in United States.
Trial summary
This study will explore clinical and genetic aspects of Usher syndrome, an inherited disease causing deafness or impaired hearing, visual problems, and, in some cases, unsteadiness or balance problems. Patients with type 1 Usher syndrome usually are deaf from birth and have speech and balance problems. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Retinitis Pigmentosa Syndromic, Congenital Deafness, Usher Syndrome
- How many people
- 249 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Mar 2005to 30 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Eligible participants must:
- have documented neurosensory hearing loss and retinitis pigmentosa and fulfill the clinical characteristics for USH1, USH2 and USH3 as defined by the Usher syndrome consortium. ; OR
- be unaffected family members of a proband with Usher s syndrome, primarily parents and siblings. Family members will be considered unaffected by history if they have had previous normal ophthalmologic and hearing examinations and if they don't have decreased night or peripheral vision.
Who cannot join
- Patients will be ineligible if they:
- had an intrauterine infection, perinatal/congenital infections, or intrauterine and birth complications. These conditions can result in damage to both the auditory or visual system.
- have concurrent inherited or acquired conditions that affect the visual and/or auditory system and significantly alter the phenotype.
- Both affected and unaffected individuals will be ineligible if they:
- Are unwilling or unable to provide a blood sample or unable to undergo the study procedures.
- Are younger than 2 years old.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
Queens College of the City University of New York
New York, New York
About this study
This study will explore clinical and genetic aspects of Usher syndrome, an inherited disease causing deafness or impaired hearing, visual problems, and, in some cases, unsteadiness or balance problems. Patients with type 1 Usher syndrome usually are deaf from birth and have speech and balance problems. Patients with type 2 disease generally are hearing impaired but have no balance problems. Patients with type 3 disease have progressive hearing loss and balance problems. All patients develop retinitis pigmentosa, an eye disease that causes poor night vision and eventually, blindness.
Patients of any age with Usher syndrome may be eligible for this study. Patients who have had eye and hearing evaluations are asked to send their medical records to the research team at the National Eye Institute (NEI) for review. They are also asked to have a blood sample drawn by a medical professional and sent to NEI for genetic analysis. Finally, they are interviewed about their family histories, particularly about other relative with eye disease. Patients who have not been evaluated previously have the following tests and procedures at NIH:
Read more
- Family medical history, especially regarding eye disease. A family tree is drawn.
- Blood draw for genetic studies of Usher syndrome.
- Eye examination to assess visual acuity and eye pressure, and to examine pupils, lens, retina, and eye movements.
- Electroretinogram (ERG) to test the function of visual cells. Wearing eye patches, the patient sits in a dark room for 30 minutes. Electrodes are taped to the forehead and the eye patches are removed. The surface of the eye is numbed with eye drops and contact lenses are placed on the eyes. The patient looks inside a hollow, dark globe and sees a series of light flashes. Then a light is turned on inside the globe and more flashes appear. The contact lenses sense small electrical signals generated by the retina when the light flashes.
- Fluorescein angiography to evaluate the eye's blood vessels. A yellow dye is injected into an arm vein and travels to the blood vessels in the eyes. Pictures of the retina are taken using a camera that flashes a blue light into the eye. The pictures show if any dye has leaked from the vessels into the retina, indicating possible blood vessel abnormality.
- Hearing tests to help determine the patient's type of Usher syndrome. Tests to evaluate hearing include examination of both ears with an otoscope, evaluation of the middle ear and inner ear, and hearing tests using earphones that deliver tones and words the subject listens and responds to.
- Vestibular testing for balance function. Balance testing involves three procedures:
Videonystagmography: This test records eye movements with little cameras. First the patient follows the movements of some small lights. Next, while wearing goggles, the patient lies on an exam table and turns to the right and left. Lastly, a soft stream of air is blown into the patient's ears four times, once in each ear with cool air and once in each ear with warm air.
Rotary chair test: With electrodes placed on the forehead, the patient sits in a rotary chair in a dark room. Several red lights appear on the wall of the room and the patient follows the lights as they move back and forth. Then the chair turns at several speeds, all slower than a merry-go-round.
Vestibular evoked potential: Electrodes are placed behind the patient's ear and at the base of the neck. Seated in a reclining chair and wearing earphones, the patient hears a brief series of loud clicking sounds. When the sounds are on, the patient is asked to lift his or her head up a few inches from the chair. The electrodes record information from the muscles in the neck as the sounds enter the ear.
Read the detailed description
Background and objectives:
The Usher syndromes are a group of clinically variable and genetically heterogeneous autosomal recessive syndromes. On the basis of clinical findings, at least three types exist. Patients with Usher type I are born deaf, have vestibular problems, and are thought to perceive night blindness in early childhood. Patients with Usher type II are born with a hearing deficit but are able to develop intelligible speech, do not have balance problems; night vision problems, and visual field changes are noted later. Patients with Usher type III are born with relatively good hearing that deteriorates over a decade or more; they can have progressive balance problems and they report night blindness in childhood or teens. Seven genes have been mapped so far for Usher type I while five of these genes have been identified. For Usher type II, four genes have been mapped and three of these have been identified while there is one cloned gene for Usher type III. Quite a lot of information is still unknown regarding the genetic nature of this syndrome. The picture of the three clinical types of Usher syndrome has also not been well studied up to this point and cross sectional studies seems to be the only source of the information available so far, regarding the natural history of the disease. The aim of this protocol is to better study the natural history of the disease and also make specific genotype-phenotype correlations.
Study population:
A total of 200 participants, including patients affected with all three clinical types of Usher syndrome and up to 200 unaffected relatives will be enrolled to the protocol. Unaffected family members, primarily parents and siblings will be enrolled to provide a blood sample when considered helpful for linkage analysis. Family members will be considered unaffected if they have had a previous normal examination and they don t have any symptoms of decreased night or peripheral vision.
Methods:
Participants will undergo ophthalmologic, audiologic and vestibular evaluation in order to be clinically characterized. Blood will be obtained by all participating subjects for the molecular studies. Patients who cannot come to NIH or a collaborating Institution for participation will be asked to provide a blood sample for genotyping and a copy of their ophthalmologic, audiology and vestibular records, to classify phenotype. Each off-site participant will be consented over the phone by an NEI investigator. All participants will be requested to fill out a questionnaire.
Outcome measures:
Affected participants will be phenotypically categorized in one of the three clinical types based on audiology and vestibular findings
- Conditions
- Retinitis Pigmentosa Syndromic, Congenital Deafness, Usher Syndrome, Retinitis Pigmentosa and Deafness, Retinitis Pigmentosa
- Keywords
- Usher Syndrome, Retinitis Pigmentosa, Congenital Deafness
- Medical subject headings
- Usher Syndromes, Retinitis Pigmentosa, Deafness
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcomes of interest are the probands genotype and phenotype.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2005 (estimated)
- Study start21 Mar 2005
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Retinitis Pigmentosa SyndromicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Wadih Zein, M.D., Principal investigator, National Eye Institute (NEI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00106743
- Sponsor's protocol ID
- 050096
- Other IDs
- 05-EI-0096
- Status last verified
- 30 Apr 2019
- First submitted
- 29 Mar 2005
- Last updated
- 12 Dec 2019
- Results posted
- No
Publications
Smith RJ, Berlin CI, Hejtmancik JF, Keats BJ, Kimberling WJ, Lewis RA, Moller CG, Pelias MZ, Tranebjaerg L. Clinical diagnosis of the Usher syndromes. Usher Syndrome Consortium. Am J Med Genet. 1994 Mar 1;50(1):32-8. doi: 10.1002/ajmg.1320500107.
PubMed 8160750Keats BJ, Corey DP. The usher syndromes. Am J Med Genet. 1999 Sep 24;89(3):158-66.
PubMed 10704190Fishman GA, Kumar A, Joseph ME, Torok N, Anderson RJ. Usher's syndrome. Ophthalmic and neuro-otologic findings suggesting genetic heterogeneity. Arch Ophthalmol. 1983 Sep;101(9):1367-74. doi: 10.1001/archopht.1983.01040020369005.
PubMed 6604514
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural History and Genetic Studies of Usher Syndrome
- ClinicalTrials.gov ID
- NCT00106743
- Acronym / sponsor ID
- 050096
- Conditions
- Retinitis Pigmentosa Syndromic, Congenital Deafness, Usher Syndrome, Retinitis Pigmentosa and Deafness, Retinitis Pigmentosa
- Keywords
- Usher Syndrome, Retinitis Pigmentosa, Congenital Deafness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- 21 Mar 2005
- Study completion
- 30 Apr 2019
- First posted
- 30 Mar 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will explore clinical and genetic aspects of Usher syndrome, an inherited disease causing deafness or impaired hearing, visual problems, and, in some cases, unsteadiness or balance problems. Patients with type 1 Usher syndrome usually are deaf from birth and have speech and balance problems. Patients with type 2 disease generally are hearing impaired but have no balance problems. Patients with type 3 disease have progressive hearing loss and balance problems. All patients develop retinitis pigmentosa, an eye disease that causes poor night vision and eventually, blindness.
Patients of any age with Usher syndrome may be eligible for this study. Patients who have had eye and hearing evaluations are asked to send their medical records to the research team at the National Eye Institute (NEI) for review. They are also asked to have a blood sample drawn by a medical professional and sent to NEI for genetic analysis. Finally, they are interviewed about their family histories, particularly about other relative with eye disease. Patients who have not been evaluated previously have the following tests and procedures at NIH:
- Family medical history, especially regarding eye disease. A family tree is drawn.
- Blood draw for genetic studies of Usher syndrome.
- Eye examination to assess visual acuity and eye pressure, and to examine pupils, lens, retina, and eye movements.
- Electroretinogram (ERG) to test the function of visual cells. Wearing eye patches, the patient sits in a dark room for 30 minutes. Electrodes are taped to the forehead and the eye patches are removed. The surface of the eye is numbed with eye drops and contact lenses are placed on the eyes. The patient looks inside a hollow, dark globe and sees a series of light flashes. Then a light is turned on inside the globe and more flashes appear. The contact lenses sense small electrical signals generated by the retina when the light flashes.
- Fluorescein angiography to evaluate the eye's blood vessels. A yellow dye is injected into an arm vein and travels to the blood vessels in the eyes. Pictures of the retina are taken using a camera that flashes a blue light into the eye. The pictures show if any dye has leaked from the vessels into the retina, indicating possible blood vessel abnormality.
- Hearing tests to help determine the patient's type of Usher syndrome. Tests to evaluate hearing include examination of both ears with an otoscope, evaluation of the middle ear and inner ear, and hearing tests using earphones that deliver tones and words the subject listens and responds to.
- Vestibular testing for balance function. Balance testing involves three procedures:
Videonystagmography: This test records eye movements with little cameras. First the patient follows the movements of some small lights. Next, while wearing goggles, the patient lies on an exam table and turns to the right and left. Lastly, a soft stream of air is blown into the patient's ears four times, once in each ear with cool air and once in each ear with warm air.
Rotary chair test: With electrodes placed on the forehead, the patient sits in a rotary chair in a dark room. Several red lights appear on the wall of the room and the patient follows the lights as they move back and forth. Then the chair turns at several speeds, all slower than a merry-go-round.
Vestibular evoked potential: Electrodes are placed behind the patient's ear and at the base of the neck. Seated in a reclining chair and wearing earphones, the patient hears a brief series of loud clicking sounds. When the sounds are on, the patient is asked to lift his or her head up a few inches from the chair. The electrodes record information from the muscles in the neck as the sounds enter the ear.
Detailed description
Background and objectives:
The Usher syndromes are a group of clinically variable and genetically heterogeneous autosomal recessive syndromes. On the basis of clinical findings, at least three types exist. Patients with Usher type I are born deaf, have vestibular problems, and are thought to perceive night blindness in early childhood. Patients with Usher type II are born with a hearing deficit but are able to develop intelligible speech, do not have balance problems; night vision problems, and visual field changes are noted later. Patients with Usher type III are born with relatively good hearing that deteriorates over a decade or more; they can have progressive balance problems and they report night blindness in childhood or teens. Seven genes have been mapped so far for Usher type I while five of these genes have been identified. For Usher type II, four genes have been mapped and three of these have been identified while there is one cloned gene for Usher type III. Quite a lot of information is still unknown regarding the genetic nature of this syndrome. The picture of the three clinical types of Usher syndrome has also not been well studied up to this point and cross sectional studies seems to be the only source of the information available so far, regarding the natural history of the disease. The aim of this protocol is to better study the natural history of the disease and also make specific genotype-phenotype correlations.
Study population:
A total of 200 participants, including patients affected with all three clinical types of Usher syndrome and up to 200 unaffected relatives will be enrolled to the protocol. Unaffected family members, primarily parents and siblings will be enrolled to provide a blood sample when considered helpful for linkage analysis. Family members will be considered unaffected if they have had a previous normal examination and they don t have any symptoms of decreased night or peripheral vision.
Methods:
Participants will undergo ophthalmologic, audiologic and vestibular evaluation in order to be clinically characterized. Blood will be obtained by all participating subjects for the molecular studies. Patients who cannot come to NIH or a collaborating Institution for participation will be asked to provide a blood sample for genotyping and a copy of their ophthalmologic, audiology and vestibular records, to classify phenotype. Each off-site participant will be consented over the phone by an NEI investigator. All participants will be requested to fill out a questionnaire.
Outcome measures:
Affected participants will be phenotypically categorized in one of the three clinical types based on audiology and vestibular findings
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- have documented neurosensory hearing loss and retinitis pigmentosa and fulfill the clinical characteristics for USH1, USH2 and USH3 as defined by the Usher syndrome consortium. ; OR
- be unaffected family members of a proband with Usher s syndrome, primarily parents and siblings. Family members will be considered unaffected by history if they have had previous normal ophthalmologic and hearing examinations and if they don't have decreased night or peripheral vision.
Key exclusion criteria (6 listed)
- had an intrauterine infection, perinatal/congenital infections, or intrauterine and birth complications. These conditions can result in damage to both the auditory or visual system.
- have concurrent inherited or acquired conditions that affect the visual and/or auditory system and significantly alter the phenotype.
- Are unwilling or unable to provide a blood sample or unable to undergo the study procedures.
- Are younger than 2 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary outcomes of interest are the probands genotype and phenotype.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
- Background: PubMed 8160750Smith RJ, Berlin CI, Hejtmancik JF, Keats BJ, Kimberling WJ, Lewis RA, Moller CG, Pelias MZ, Tranebjaerg L. Clinical diagnosis of the Usher syndromes. Usher Syndrome Consortium. Am J Med Genet. 1994 Mar 1;50(1):32-8. doi: 10.1002/ajmg.1320500107.
- Background: PubMed 10704190Keats BJ, Corey DP. The usher syndromes. Am J Med Genet. 1999 Sep 24;89(3):158-66.
- Background: PubMed 6604514Fishman GA, Kumar A, Joseph ME, Torok N, Anderson RJ. Usher's syndrome. Ophthalmic and neuro-otologic findings suggesting genetic heterogeneity. Arch Ophthalmol. 1983 Sep;101(9):1367-74. doi: 10.1001/archopht.1983.01040020369005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wadih Zein, M.D. principal investigator
National Eye Institute (NEI)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinitis Pigmentosa Syndromic and Congenital Deafness, run by National Eye Institute (NEI) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcomes of interest are the probands genotype and phenotype. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00106743, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2019.