Hereditary Eye DiseaseNCT00001732
Screening for Studies on Inherited Eye Diseases
An observational study of Hereditary Eye Disease, run by National Eye Institute (NEI) at 1 site in United States.
Trial summary
This screening protocol is designed to help recruit patients for National Eye Institute (NEI) studies on inherited eye diseases. Patients must meet specific requirements of a research study, and this protocol serves as a first step for admitting patients to an appropriate program. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hereditary Eye Disease
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 1998to 20 May 2008
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Inclusion and exclusion criteria vary with the particular protocol for which a patient is being screened. in addition to those diagnoses currently under study, subjects with unusual, interesting, or unknown conditions that require the establishment of a diagnosis, may be eligible for inclusion in this study.
- The subjects source for this study will be from referrals by medical practitioners in the private sector, clinics, hospitals, medical institutions, and the Occupational Medical Services at the National Institutes of Health
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Screening Study for the Evaluation and Diagnosis of Potential Research Subjects With Inherited Ophthalmic Diseases
This screening protocol is designed to help recruit patients for National Eye Institute (NEI) studies on inherited eye diseases. Patients must meet specific requirements of a research study, and this protocol serves as a first step for admitting patients to an appropriate program.
Candidates will undergo a medical history, physical examination, eye examination and blood test. The eye examination includes measurement of eye pressure and dilation of the pupils to fully examine the lens, vitreous and retina. Specialized tests will be done only if needed to determine eligibility for a specific study in NEI's Ophthalmic Genetics Clinic. These include routine laboratory tests, non-invasive imaging, questionnaires and other standard tests, as well as specialized tests and procedures where needed, including genetic testing. Photographs of the eye may be taken. Patients will be asked questions about family history, especially relating to eye disease or cataracts, and a family tree will be drawn. A blood sample will also be drawn.
When the screening is completed, patients will be informed of their options to participate in a study. Patients who are ineligible for a current study will be informed of alternative treatments or options. No treatment is offered under this protocol.
Read the detailed description
This protocol is designed for the screening of patients with either diagnosed or undiagnosed conditions, and serves as a first step for individuals who may be eligible, and wish to participate in NEI clinical research studies.
Each individual will be thoroughly evaluated during the screening process to determine if they are suitable candidates for inclusion in any of the NEI ongoing studies. The screening evaluation will include past and current medical histories, and an appropriate physical examination. Other routine diagnostic procedures and tests may also be completed in order to help determine a subject's eligibility. These tests and procedures are of minimal risk and will be described in more detail in section III: "Study Procedures". Once the screening process is completed and their eligibility is assessed, the subjects will be informed of their options to participate in one or more of the current clinical research studies. If no appropriate protocol is identified, recommendations for other treatment options may be given to the individual, their primary doctor, or referring physician.
- Conditions
- Hereditary Eye Disease
- Keywords
- Genetics, Diagnosis, Screening Protocol, Ophthalmic Genetic Diseases, Genetic Testing, Family Studies
- Medical subject headings
- Eye Diseases, Hereditary, Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study start25 Feb 1998
- Study completion20 May 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary Eye DiseaseStudies 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
- Enrolment
- 800 participants
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001732
- Sponsor's protocol ID
- 980072
- Other IDs
- 98-EI-0072
- Status last verified
- 20 May 2008
- First submitted
- 3 Nov 1999
- Last updated
- 2 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening Study for the Evaluation and Diagnosis of Potential Research Subjects With Inherited Ophthalmic Diseases
- ClinicalTrials.gov ID
- NCT00001732
- Acronym / sponsor ID
- 980072
- Conditions
- Hereditary Eye Disease
- Keywords
- Genetics, Diagnosis, Screening Protocol, Ophthalmic Genetic Diseases, Genetic Testing, Family Studies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- 25 Feb 1998
- Study completion
- 20 May 2008
- First posted
- 4 Nov 1999 (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 screening protocol is designed to help recruit patients for National Eye Institute (NEI) studies on inherited eye diseases. Patients must meet specific requirements of a research study, and this protocol serves as a first step for admitting patients to an appropriate program.
Candidates will undergo a medical history, physical examination, eye examination and blood test. The eye examination includes measurement of eye pressure and dilation of the pupils to fully examine the lens, vitreous and retina. Specialized tests will be done only if needed to determine eligibility for a specific study in NEI's Ophthalmic Genetics Clinic. These include routine laboratory tests, non-invasive imaging, questionnaires and other standard tests, as well as specialized tests and procedures where needed, including genetic testing. Photographs of the eye may be taken. Patients will be asked questions about family history, especially relating to eye disease or cataracts, and a family tree will be drawn. A blood sample will also be drawn.
When the screening is completed, patients will be informed of their options to participate in a study. Patients who are ineligible for a current study will be informed of alternative treatments or options. No treatment is offered under this protocol.
Detailed description
This protocol is designed for the screening of patients with either diagnosed or undiagnosed conditions, and serves as a first step for individuals who may be eligible, and wish to participate in NEI clinical research studies.
Each individual will be thoroughly evaluated during the screening process to determine if they are suitable candidates for inclusion in any of the NEI ongoing studies. The screening evaluation will include past and current medical histories, and an appropriate physical examination. Other routine diagnostic procedures and tests may also be completed in order to help determine a subject's eligibility. These tests and procedures are of minimal risk and will be described in more detail in section III: "Study Procedures". Once the screening process is completed and their eligibility is assessed, the subjects will be informed of their options to participate in one or more of the current clinical research studies. If no appropriate protocol is identified, recommendations for other treatment options may be given to the individual, their primary doctor, or referring physician.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Inclusion and exclusion criteria vary with the particular protocol for which a patient is being screened. in addition to those diagnoses currently under study, subjects with unusual, interesting, or unknown conditions that require the establishment of a diagnosis, may be eligible for inclusion in this study.
- The subjects source for this study will be from referrals by medical practitioners in the private sector, clinics, hospitals, medical institutions, and the Occupational Medical Services at the National Institutes of Health
Key exclusion criteria (0 listed)
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
Not reported in the source record.
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 2 Jul 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hereditary Eye Disease, run by National Eye Institute (NEI) at 1 site 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 2 inclusion and 0 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 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Where can I read the original study information?
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 2 Jul 2017.