Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001861
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
1999-11-03
Brief Title:
Screening for Studies on Nystagmus and Strabismus
Sponsor:
National Eye Institute NEI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Screening Study for the Evaluation and Diagnosis of Potential Research Subjects With Nystagmus or Strabismus
Status:
COMPLETED
Status Verified Date:
2007-12-10
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 screening protocol is designed to help recruitment patients for National Eye Institute NEI studies on nystagmus and strabismus 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 nystagmus or strabismus study These include routine laboratory tests non-invasive imaging questionnaires and other standard tests If needed a test called oculography may be done to record eye movements There are two procedures for recording and documenting these movements In the infrared system the patient wears a pair of glasses or goggles and looks at a red light while the head is kept steady In the search coil system the eye is numbed with anesthetic eye drops and a soft contact lens is placed on the eye Then the patient looks at a red light while the head is held still Each oculography session lasts 20 to 30 minutes Photographs of the eye may be taken
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
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 nystagmus or strabismus study These include routine laboratory tests non-invasive imaging questionnaires and other standard tests If needed a test called oculography may be done to record eye movements There are two procedures for recording and documenting these movements In the infrared system the patient wears a pair of glasses or goggles and looks at a red light while the head is kept steady In the search coil system the eye is numbed with anesthetic eye drops and a soft contact lens is placed on the eye Then the patient looks at a red light while the head is held still Each oculography session lasts 20 to 30 minutes Photographs of the eye may be taken
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 National Eye Institute 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 subjects eligibility These tests and procedures are of minimal risk Once the screening process is completed and their eligibility 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
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 subjects eligibility These tests and procedures are of minimal risk Once the screening process is completed and their eligibility 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| 99-EI-0035 | None | None | None |