Evaluation and Treatment of Patients With Corneal and External Diseases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00008541
Recruitment Status : Completed
First Posted : January 15, 2001
Last Update Posted : July 2, 2017
Information provided by:
National Institutes of Health Clinical Center (CC)

Brief 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.

Condition or disease
Blepharitis Conjunctivitis Corneal Disease Dacryoadenitis Dacryocystitis Keratitis

Detailed Description:

This protocol will permit the specialists in cornea and external disease at the NEI to identify, follow and provide "standard of care" treatment to patients with various corneal and external disease and anterior segment disorders. By providing long-term follow-up and treatment for a variety of corneal and external diseases, the corneal specialists at NEI will be better able to identify research hypotheses about these diseases in addition to maintaining their clinical skills. Another purpose of the protocol is to accumulate a cohort of patients with corneal diseases for possible participation in new NEI clinical trials and epidemiological protocols. The availability of cohorts of patients with a spectrum of anterior segment diseases will be valuable for the training of fellows, an important component of the mission of the NEI. The ability to provide follow-up and care will also facilitate referral efforts for NEI protocols.

The cornea specialists at the National Eye Institute will be free to choose those conditions that interest them. However, the total number of patients that can be enrolled in the protocol will be restricted. This protocol is not designed to test any new treatments. Any evaluations or treatment under this protocol will be based on the current standard of care as appropriate for the relevant ocular disease.

Participants in this evaluation and treatment protocol will be evaluated for potential eligibility in other NEI clinical trials or epidemiologic protocols as they are developed. If eligible, they may be asked to participate in the new protocol; however, they will not be required to enter any protocol and their decision to participate will be entirely voluntary.

Study Type : Observational
Enrollment : 600 participants
Official Title: Evaluation and Treatment of Corneal and External Diseases and Anterior Segment Disorders
Study Start Date : January 2, 2001
Study Completion Date : March 6, 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

    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.


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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00008541

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Eye Institute (NEI) Identifier: NCT00008541     History of Changes
Other Study ID Numbers: 010046
First Posted: January 15, 2001    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: March 6, 2009

Keywords provided by National Institutes of Health Clinical Center (CC):
Corneal Infiltrates
Corneal Eye Disease

Additional relevant MeSH terms:
Corneal Diseases
Conjunctival Diseases
Eye Diseases
Eyelid Diseases
Lacrimal Apparatus Diseases