Blepharitis Clinical Trial
Official title:
Evaluation and Treatment of Corneal and External Diseases and Anterior Segment Disorders
Verified date | March 6, 2009 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study offers evaluation and treatment for patients with certain corneal and external
diseases of the eye (diseases of the surface of the eye and its surrounding structures). The
protocol is not designed to test new treatments; rather, patients will receive current
standard of care treatments. The purpose of the study is twofold: 1) to allow National Eye
Institute physicians to increase their knowledge of various corneal and external conditions
and identify possible new avenues of research in this area; and 2) to establish a pool of
patients who may be eligible for new studies as they are developed. (Participants in this
protocol will not be required to join a new study; the decision will be voluntary.)
Children and adults with corneal or external eye diseases may be eligible for this study.
Candidates will be screened with a medical history, brief physical examination, thorough eye
examination and blood test. The eye examination includes measurements of eye pressure and
visual acuity (ability to see the vision chart) and dilation of the pupils to examine the
lens and retina (back part of the eye). Patients will also undergo the following procedures:
1. Eye photography - Special photographs of the inside of the eye to help evaluate the
status of the cornea and conjunctiva (the most superficial layer of the eye) evaluate
changes that may occur in the future. From two to 20 pictures may be taken, depending on
the eye condition. The camera flashes a bright light into the eye for each picture.
2. Conjunctival or lacrimal gland biopsy - A small piece of the conjunctiva or the lacrimal
(tear) gland, is removed for examination under the microscope. Anesthetic drops and
possibly an injection of anesthetic are given to numb the eye. An antibiotic ointment
and patch may be placed over the eye for several hours after the procedure.
Participants will be followed at least 3 years. Follow-up visits are scheduled according to
the standard of care for the individual patient's eye problem. Vision will be checked at each
visit, and some of the tests described above may be repeated to follow the progress of
disease and evaluate the response to any treatment that is given.
Status | Completed |
Enrollment | 600 |
Est. completion date | March 6, 2009 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years and older |
Eligibility |
- INCLUSION CRITERIA: 1. Corneal and external diseases or anterior segment disorders. 2. If adult, ability to provide informed consent. Cognitively impaired adults will not be enrolled. 3. Infants under the age of 2 years are excluded. Children greater than or equal to age of 2 years willing to provide assent who meet other study requirements are eligible to participate. EXCLUSION CRITERIA: Subjects may be excluded if they 1. Are unwilling or unable to cooperate with study procedures. 2. Have any disease or condition with less than 3 year expected survival. 3. There are no medical exclusions. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Eye Institute (NEI) |
United States,
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