CataractNCT00559234
Potential Research Participants for Future Studies of Inherited Eye Diseases
An observational study of Cataract and Glaucoma, run by National Eye Institute (NEI) at 1 site in United States.
Trial summary
This study will evaluate potential candidates for future clinical research studies related to diagnosed or undiagnosed genetic eye disorders or diseases. It will not test any new treatments, but it may arrange for standard treatments for existing eye disorders. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cataract, Glaucoma, Retinitis Pigmentosa
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2007to 3 Oct 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
- Subjects will be able to enroll if they:
- Have either a diagnosed or undiagnosed genetic eye disease.
- Have the ability to understand and sign an informed consent or have a parent/legal guardian who is able to do so for them.
Who cannot join
- Subjects will not be eligible if they:
- Are unwilling or unable to be followed and treated at the NEI Clinical Center.
- Have any systemic diseases that compromise the ability to provide adequate ophthalmologic examination or treatment.
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: Evaluation and Treatment Protocol for Potential Research Participants With Inherited Ophthalmic Diseases
This study will evaluate potential candidates for future clinical research studies related to diagnosed or undiagnosed genetic eye disorders or diseases. It will not test any new treatments, but it may arrange for standard treatments for existing eye disorders. The purpose of the study is to train eye doctors and medical researchers at the National Institutes of Health in appropriate methods and procedures for treating patients with genetic eye diseases, and to expand the pool of possible participants for future research studies and trials on eye health.
Volunteers for this study may be adults and minor children who have been diagnosed with or are at risk for having a genetic eye disease. Candidates may not have any other medical conditions that would interfere with the researchers' ability to perform the examinations and procedures required for this study.
Participants will give a complete medical and family history and undergo a series of tests and procedures as part of this research study. The procedures include a full eye examination and vision testing, electrooculography and an electroretinogram to examine the function of the retina, and flourescein angiography to provide information on the flow of blood in the participant's eyes. Participants will provide research material for further studies by giving a blood sample to be held for genetic testing and analysis, and adult participants will also undergo a skin biopsy to provide cell tissue for additional research material. At each clinic visit, participants will receive treatment for their genetic eye disease as needed, including medications or surgical procedures. Participants may remain a part of this study for up to three years.
Read the detailed description
The National Eye Institute is conducting a study to evaluate participants with either diagnosed or undiagnosed genetic conditions who may be eligible and wish to participate in other NEI clinical research studies. The primary purpose of this evaluation and treatment protocol is to provide a resource of patients for specific new research protocols and for staff and fellowship training. A secondary purpose is to provide long-term follow-up and treatment for a variety of genetic eye diseases so that the genetic specialists at NEI will be better able to identify research hypotheses for these diseases, which may lead to ideas for future protocols. Finally, the ability to provide long-term follow-up and care will also facilitate referral efforts for new NEI protocols. As a by-product of this research activity, the participants will help the investigators to maintain their clinical skills.
- Conditions
- Cataract, Glaucoma, Retinitis Pigmentosa, Macular Degeneration, Strabismus
- Keywords
- Optic Nerve, Retina, Cornea, Lens, Ocular Genetic Diseases, Inherited Eye Disease, Genetic Eye Disease
- Medical subject headings
- Cataract, Glaucoma, Retinitis Pigmentosa, Macular Degeneration, Strabismus, Corneal Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2007 (estimated)
- Study start9 Nov 2007
- Study completion3 Oct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CataractStudies 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
- Time perspective
- Prospective
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00559234
- Sponsor's protocol ID
- 080017
- Other IDs
- 08-EI-0017
- Status last verified
- 3 Oct 2008
- First submitted
- 15 Nov 2007
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
MacDonald IM, Mah DY. Summary of heritable ocular disorders and selected systemic conditions with eye findings. Ophthalmic Genet. 2000 Mar;21(1):29-49.
PubMed 10779848MacDonald IM, Haney PM, Musarella MA. Summary of ocular genetic disorders and inherited systemic conditions with eye findings. Ophthalmic Genet. 1998 Mar;19(1):1-17. doi: 10.1076/opge.19.1.1.2181.
PubMed 9587925
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
- Evaluation and Treatment Protocol for Potential Research Participants With Inherited Ophthalmic Diseases
- ClinicalTrials.gov ID
- NCT00559234
- Acronym / sponsor ID
- 080017
- Conditions
- Cataract, Glaucoma, Retinitis Pigmentosa, Macular Degeneration, Strabismus
- Keywords
- Optic Nerve, Retina, Cornea, Lens, Ocular Genetic Diseases, Inherited Eye Disease, Genetic Eye Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- 9 Nov 2007
- Study completion
- 3 Oct 2008
- First posted
- 16 Nov 2007 (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 evaluate potential candidates for future clinical research studies related to diagnosed or undiagnosed genetic eye disorders or diseases. It will not test any new treatments, but it may arrange for standard treatments for existing eye disorders. The purpose of the study is to train eye doctors and medical researchers at the National Institutes of Health in appropriate methods and procedures for treating patients with genetic eye diseases, and to expand the pool of possible participants for future research studies and trials on eye health.
Volunteers for this study may be adults and minor children who have been diagnosed with or are at risk for having a genetic eye disease. Candidates may not have any other medical conditions that would interfere with the researchers' ability to perform the examinations and procedures required for this study.
Participants will give a complete medical and family history and undergo a series of tests and procedures as part of this research study. The procedures include a full eye examination and vision testing, electrooculography and an electroretinogram to examine the function of the retina, and flourescein angiography to provide information on the flow of blood in the participant's eyes. Participants will provide research material for further studies by giving a blood sample to be held for genetic testing and analysis, and adult participants will also undergo a skin biopsy to provide cell tissue for additional research material. At each clinic visit, participants will receive treatment for their genetic eye disease as needed, including medications or surgical procedures. Participants may remain a part of this study for up to three years.
Detailed description
The National Eye Institute is conducting a study to evaluate participants with either diagnosed or undiagnosed genetic conditions who may be eligible and wish to participate in other NEI clinical research studies. The primary purpose of this evaluation and treatment protocol is to provide a resource of patients for specific new research protocols and for staff and fellowship training. A secondary purpose is to provide long-term follow-up and treatment for a variety of genetic eye diseases so that the genetic specialists at NEI will be better able to identify research hypotheses for these diseases, which may lead to ideas for future protocols. Finally, the ability to provide long-term follow-up and care will also facilitate referral efforts for new NEI protocols. As a by-product of this research activity, the participants will help the investigators to maintain their clinical skills.
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Have either a diagnosed or undiagnosed genetic eye disease.
- Have the ability to understand and sign an informed consent or have a parent/legal guardian who is able to do so for them.
Key exclusion criteria (3 listed)
- Are unwilling or unable to be followed and treated at the NEI Clinical Center.
- Have any systemic diseases that compromise the ability to provide adequate ophthalmologic examination or treatment.
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.
- Background: PubMed 10779848MacDonald IM, Mah DY. Summary of heritable ocular disorders and selected systemic conditions with eye findings. Ophthalmic Genet. 2000 Mar;21(1):29-49.
- Background: PubMed 9587925MacDonald IM, Haney PM, Musarella MA. Summary of ocular genetic disorders and inherited systemic conditions with eye findings. Ophthalmic Genet. 1998 Mar;19(1):1-17. doi: 10.1076/opge.19.1.1.2181.
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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 Cataract and Glaucoma, 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 3 inclusion and 3 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?
On the ClinicalTrials.gov record for NCT00559234, which also lists 2 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 2 Jul 2017.