Ignite Creation Date:
2024-05-05 @ 7:23 PM
Last Modification Date:
2024-10-26 @ 9:47 AM
Study NCT ID:
NCT00655096
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2008-04-08
Brief Title:
Screening for Research Participants
Sponsor:
National Eye Institute NEI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Screening Protocol for the Evaluation and Diagnosis of Potential Research Participants
Status:
RECRUITING
Status Verified Date:
2024-08-27
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 hisher 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 NEIs 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 protocols 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 eg urine and tissue eg 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
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 hisher 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 NEIs 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 protocols 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 eg urine and tissue eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 08-EI-0102 | None | None | None |