Protocol Number: 01-EI-0046

Title:

Evaluation and Treatment Protocol of Patients with Corneal and External Diseases

Number:

01-EI-0046

Summary:

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.

Sponsoring Institute:

National Eye Institute (NEI)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria:

Must have the ability to understand and sign an informed consent or assent form. The consent must be signed prior to enrollment. Children of all ages are eligible to be included in this protocol.

Patients will be excluded from this study if they are unable or unwilling to give informed consent or they are unwilling to be followed and treated at the NEI clinical center for at least the next three years.

Special Instructions: Currently Not Provided

Keywords:

Keratitis

Conjunctivitis

Meibomitis

Corneal Infiltrates

Dacryocystitis

Blepharitis

Dacryoadenitis

Recruitment Keywords:

Corneal Eye Disease

Keratitis

Blepharitis

Conditions:

Blepharitis

Conjunctivitis

Corneal Disease

Dacryoadenitis

Dacryocystitis

Keratitis

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations: Not Provided

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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Warren Grant Magnuson Clinical Center (CC)
National Institutes of Health (NIH)
Bethesda, Maryland 20892. Last update: 10/27/2004