Screening for Research Subjects With Anterior Segment Diseases
Primary Purpose
Eye Diseases
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Eye Diseases focused on measuring Cornea, Conjunctiva, Keratitis, Ocular Surface, Inflammation, Evaluation, Screening, Ocular Surface Disease, Eye, Ocular Disease, Anterior Segment Disease
Eligibility Criteria
ELIGIBILITY CRITERIA: To participate in this screening study, a patient must have a history of anterior segment disease. Patients of all ages are eligible.
Sites / Locations
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00088348
First Posted
July 23, 2004
Last Updated
June 30, 2017
Sponsor
National Eye Institute (NEI)
1. Study Identification
Unique Protocol Identification Number
NCT00088348
Brief Title
Screening for Research Subjects With Anterior Segment Diseases
Official Title
Screening Study for the Evaluation and Diagnosis of Potential Research Subjects With Anterior Segment Disease
Study Type
Observational
2. Study Status
Record Verification Date
August 20, 2008
Overall Recruitment Status
Completed
Study Start Date
July 13, 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 20, 2008 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Eye Institute (NEI)
4. Oversight
5. Study Description
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 patient's eye disease.
Other diagnostic tests as needed.
DNA testing to look for a genetic pattern associated with the patient's 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eye Diseases
Keywords
Cornea, Conjunctiva, Keratitis, Ocular Surface, Inflammation, Evaluation, Screening, Ocular Surface Disease, Eye, Ocular Disease, Anterior Segment Disease
7. Study Design
Enrollment
600 (false)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
ELIGIBILITY CRITERIA:
To participate in this screening study, a patient must have a history of anterior segment disease. Patients of all ages are eligible.
Facility Information:
Facility Name
National Institutes of Health Clinical Center, 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
8981714
Citation
Holland EJ. Epithelial transplantation for the management of severe ocular surface disease. Trans Am Ophthalmol Soc. 1996;94:677-743.
Results Reference
background
Learn more about this trial
Screening for Research Subjects With Anterior Segment Diseases
We'll reach out to this number within 24 hrs