Eye DiseasesNCT00655096
Screening for Research Participants
An observational study of Eye Diseases, run by National Eye Institute (NEI) at 1 site in United States.
Trial summary
This study will allow National Eye Institute (NEI) doctors the opportunity to examine people with eye disease, whether the diagnosis is known or not, to determine if they are eligible for other NEI research studies. No treatment is offered in this study. Read more about this study
- Who is it for?
- Ages 2 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Eye Diseases
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2008to not given
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants can be self-referred or be referrals from medical practitioners, clinics, hospitals, or medical institutions.
Who may be able to join
- Participants will be able to enroll if they:
- Have a diagnosed ocular disease/disorder; OR
- Potentially have an unusual, interesting, or unknown ocular condition that requires the establishment of a diagnosis; OR
- Potentially participate as a disease-free control participant in an NEI clinical research study; OR
- Are an unaffected first-degree relative of a participant with either a diagnosed or undiagnosed ocular disorder; AND
- Have the ability to understand and sign an informed consent OR if they are minor children have a legal parent/guardian with the ability to do the same.
- Adults with impaired capacity to consent must have a Legally Authorized Representative (LAR) who is able to provide informed consent.
Who cannot join
- Participants will be unable to enroll if they:
- Are unwilling or unable to cooperate with the study procedures.
- Female participants of childbearing potential who are pregnant are not eligible for enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Screening Protocol for the Evaluation and Diagnosis of Potential Research Participants
This study will allow National Eye Institute (NEI) doctors the opportunity to examine people with eye disease, whether the diagnosis is known or not, to determine if they are eligible for other NEI research studies. No treatment is offered in this study.
People of all ages with various eye conditions, including genetic conditions, eye movement disorders, inflammatory eye diseases, retinal diseases and external eye diseases, may be eligible for this study.
Read more
Participants undergo various tests and procedures to diagnose or evaluate their eye disease. The procedures may include the following:
- Personal and family medical history
- Physical examination and blood tests, including genetic testing.
- Eye examination with dilation to measure visual acuity and eye pressure and to examine the front and back parts of the eye.
- Questionnaire about vision and daily activities.
- Conjunctival swab or lacrimal bland biopsy, or both: A sample of cells from the eyes is collected by swabbing the surface of the eye or by surgically removing a small sample of the surface of the eye or tear gland.
- Electroretinogram to examine retinal function: The subject sits in the dark with his or her eyes patched for 30 minutes. The patches are removed, the surface of the eyes is numbed, and contact lenses that can sense signals from the retina are placed on the eyes. The subject then watches flashing lights.
- Fluorescein angiography to examine the blood vessels in the eye: A dye is injected into a vein in the arm. The dye travels through the veins to the blood vessels in the eyes. A camera takes pictures of the dye as it flows through the blood vessels.
- Optical coherence tomography to measure retinal thickness: A machine used to examine the eyes produces cross-sectional pictures of the retina.
- Microperimetry to test how sensitive different parts of the retina are to changing levels of light. The subject sits in front of a computer and presses a button when he or she sees a light on the screen.
- Oculography to record eye movements: Eye movements are measured by contact lenses or goggles that the subject wears while watching a series of spots on a computer screen.
Read the detailed description
This protocol is designed for the screening of potential research participants with or without a defined diagnosis. This protocol will serve as a point of entry for individuals who may be eligible and wish to participate in the National Eye Institute (NEI) clinical research studies.
Patients who are referred or self-referred will be screened and evaluated during the screening process to determine whether they are suitable participants for any of the ongoing NEI research studies. The screening process may include past and current medical history, a physical examination, diagnostic procedures, and required testing used to establish a patient s diagnosis and determine his/her potential eligibility for research participation. Once the screening process is complete, patients will be informed of their options to participate in one or more of the NEI's current clinical research protocols or natural history studies. If no appropriate research protocol is available for their participation, the patient may receive potential treatment recommendations, which will be shared with the patient s primary provider and referring physician.
This protocol's secondary aim is to collect and store human biospecimens and health information for basic science laboratory research and to generate and test hypotheses. Through such studies, research investigators hope to find possible new ways to detect, treat, and even prevent or cure ophthalmological diseases. Genetic and genomic testing, and biospecimen samples such as blood, body fluid (e.g., urine), and tissue (e.g., skin) may be collected from affected or unaffected adult participants. Biospecimen samples can be obtained at the time of screening or any time after screening. These samples, combined with other clinical data, may be used for basic science laboratory research or stored and used in future research studies. Biospecimen sample collection is voluntary for all participants.
- Conditions
- Eye Diseases
- Keywords
- Eye, Photograph, Retina
- Medical subject headings
- Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Affected participants | Adults and children with either diagnosed or un-diagnosed ocular conditions. | |
| Disease free control | Adults and children without any ocular disorders. | |
| Unaffected relative | Unaffected first degree relative of a genetic ocular disease participant. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ascertain eligibility
Determine eligibility for additional NEI protocols.
Measured: At screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2008 (estimated)
- Study start20 Aug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye DiseasesStudies 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
- Cross-sectional
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
- Investigators
- Awilda V Holland, R.N., Principal investigator, National Eye Institute (NEI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00655096
- Sponsor's protocol ID
- 080102
- Other IDs
- 08-EI-0102
- Status last verified
- 14 Sep 2026
- First submitted
- 8 Apr 2008
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening Protocol for the Evaluation and Diagnosis of Potential Research Participants
- ClinicalTrials.gov ID
- NCT00655096
- Acronym / sponsor ID
- 080102
- Conditions
- Eye Diseases
- Keywords
- Eye, Photograph, Retina
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- 20 Aug 2008 (actual)
- First posted
- 9 Apr 2008 (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 allow National Eye Institute (NEI) doctors the opportunity to examine people with eye disease, whether the diagnosis is known or not, to determine if they are eligible for other NEI research studies. No treatment is offered in this study.
People of all ages with various eye conditions, including genetic conditions, eye movement disorders, inflammatory eye diseases, retinal diseases and external eye diseases, may be eligible for this study.
Participants undergo various tests and procedures to diagnose or evaluate their eye disease. The procedures may include the following:
- Personal and family medical history
- Physical examination and blood tests, including genetic testing.
- Eye examination with dilation to measure visual acuity and eye pressure and to examine the front and back parts of the eye.
- Questionnaire about vision and daily activities.
- Conjunctival swab or lacrimal bland biopsy, or both: A sample of cells from the eyes is collected by swabbing the surface of the eye or by surgically removing a small sample of the surface of the eye or tear gland.
- Electroretinogram to examine retinal function: The subject sits in the dark with his or her eyes patched for 30 minutes. The patches are removed, the surface of the eyes is numbed, and contact lenses that can sense signals from the retina are placed on the eyes. The subject then watches flashing lights.
- Fluorescein angiography to examine the blood vessels in the eye: A dye is injected into a vein in the arm. The dye travels through the veins to the blood vessels in the eyes. A camera takes pictures of the dye as it flows through the blood vessels.
- Optical coherence tomography to measure retinal thickness: A machine used to examine the eyes produces cross-sectional pictures of the retina.
- Microperimetry to test how sensitive different parts of the retina are to changing levels of light. The subject sits in front of a computer and presses a button when he or she sees a light on the screen.
- Oculography to record eye movements: Eye movements are measured by contact lenses or goggles that the subject wears while watching a series of spots on a computer screen.
Detailed description
This protocol is designed for the screening of potential research participants with or without a defined diagnosis. This protocol will serve as a point of entry for individuals who may be eligible and wish to participate in the National Eye Institute (NEI) clinical research studies.
Patients who are referred or self-referred will be screened and evaluated during the screening process to determine whether they are suitable participants for any of the ongoing NEI research studies. The screening process may include past and current medical history, a physical examination, diagnostic procedures, and required testing used to establish a patient s diagnosis and determine his/her potential eligibility for research participation. Once the screening process is complete, patients will be informed of their options to participate in one or more of the NEI's current clinical research protocols or natural history studies. If no appropriate research protocol is available for their participation, the patient may receive potential treatment recommendations, which will be shared with the patient s primary provider and referring physician.
This protocol's secondary aim is to collect and store human biospecimens and health information for basic science laboratory research and to generate and test hypotheses. Through such studies, research investigators hope to find possible new ways to detect, treat, and even prevent or cure ophthalmological diseases. Genetic and genomic testing, and biospecimen samples such as blood, body fluid (e.g., urine), and tissue (e.g., skin) may be collected from affected or unaffected adult participants. Biospecimen samples can be obtained at the time of screening or any time after screening. These samples, combined with other clinical data, may be used for basic science laboratory research or stored and used in future research studies. Biospecimen sample collection is voluntary for all participants.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Affected participants | – | –Adults and children with either diagnosed or un-diagnosed ocular conditions. |
| Disease free control | – | –Adults and children without any ocular disorders. |
| Unaffected relative | – | –Unaffected first degree relative of a genetic ocular disease participant. |
Who may qualify
- Ages
- 2 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants can be self-referred or be referrals from medical practitioners, clinics, hospitals, or medical institutions.
Key inclusion criteria (7 listed)
- Have a diagnosed ocular disease/disorder; OR
- Potentially have an unusual, interesting, or unknown ocular condition that requires the establishment of a diagnosis; OR
- Potentially participate as a disease-free control participant in an NEI clinical research study; OR
- Are an unaffected first-degree relative of a participant with either a diagnosed or undiagnosed ocular disorder; AND
- Have the ability to understand and sign an informed consent OR if they are minor children have a legal parent/guardian with the ability to do the same.
Key exclusion criteria (3 listed)
- Are unwilling or unable to cooperate with the study procedures.
- Female participants of childbearing potential who are pregnant are not eligible for enrollment.
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
ascertain eligibility
Time frame: At screening
Determine eligibility for additional NEI protocols.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Awilda V Holland, R.N. principal investigator
National Eye Institute (NEI)
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 Eye Diseases, 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 7 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: looking for participants now, as of the sponsor's last update on 26 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Awilda V Holland, R.N. ((301) 435-1831, aholland@nei.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ascertain eligibility (time frame: At screening). It is what the study was designed to measure, not a finding.
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 26 Oct 2026; AzTrials last refreshed its copy on 29 Oct 2026.