Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00088348
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2004-07-23
Brief Title:
Screening for Research Subjects With Anterior Segment Diseases
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 Anterior Segment Disease
Status:
COMPLETED
Status Verified Date:
2008-08-20
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 identify patients with anterior segment disease who may be eligible to participate in current or future NEI studies on this disease Anterior segment disease includes all disorders that affect the eye surface anterior chamber iris and ciliary body and lens of the eye The eye surface is composed of the cornea conjunctiva eyelids lacrimal and meibomian glands and the interconnecting nerves
Patients of any age with anterior segment disease may be eligible for this screening study Participants will be evaluated with some or all of the following tests and procedures depending on the nature of their eye problem
Medical history and brief physical examination
Eye examination including measurement of visual acuity eye chart and eye pressure examination of the pupils eye movements structures in the front of the eye cornea conjunctive etc the lens and the structures in the back of the eye retinal optic nerve etc
Photographs of the eye to help assess the status of the cornea and conjunctive and to evaluate any changes that may occur in the future
Assessment of tear and surface status The amount of tears the eyes can produce is measured by placing a small piece of sterile paper in the corner of the eye every 5 minutes Special orange and green dyes are placed in the eyes to determine the health status of the surface of the eye
Corneal or conjunctival biopsy A small tissue sample from the surface of the eye may be removed for laboratory examination to help diagnose a condition that is unclear For this procedure the eye is numbed with anesthetic eye drops The required tissue is collected an antibiotic ointment is placed in the eye to prevent infection and a patch may be placed over the eye for 12 to 24 hours
Blood draw for tests to study the cause of the patients eye disease
Other diagnostic tests as needed
DNA testing to look for a genetic pattern associated with the patients eye disease
Patients who are found eligible for an NEI study will be offered participation in that study Patients who are not eligible for current studies will be advised about treatment options
Patients of any age with anterior segment disease may be eligible for this screening study Participants will be evaluated with some or all of the following tests and procedures depending on the nature of their eye problem
Medical history and brief physical examination
Eye examination including measurement of visual acuity eye chart and eye pressure examination of the pupils eye movements structures in the front of the eye cornea conjunctive etc the lens and the structures in the back of the eye retinal optic nerve etc
Photographs of the eye to help assess the status of the cornea and conjunctive and to evaluate any changes that may occur in the future
Assessment of tear and surface status The amount of tears the eyes can produce is measured by placing a small piece of sterile paper in the corner of the eye every 5 minutes Special orange and green dyes are placed in the eyes to determine the health status of the surface of the eye
Corneal or conjunctival biopsy A small tissue sample from the surface of the eye may be removed for laboratory examination to help diagnose a condition that is unclear For this procedure the eye is numbed with anesthetic eye drops The required tissue is collected an antibiotic ointment is placed in the eye to prevent infection and a patch may be placed over the eye for 12 to 24 hours
Blood draw for tests to study the cause of the patients eye disease
Other diagnostic tests as needed
DNA testing to look for a genetic pattern associated with the patients eye disease
Patients who are found eligible for an NEI study will be offered participation in that study Patients who are not eligible for current studies will be advised about treatment options
Detailed Description:
This is a screening protocol that will allow the NEI clinicians to examine patients with ocular diseases in order to identify those who may be eligible to participate in other NEI studies on anterior segment disease
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 |
|---|---|---|---|
| 04-EI-0241 | None | None | None |