NCT00008541

Evaluation and Treatment of Patients With Corneal and External Diseases

Completed Last updated 2 July 2017

What this trial tests

trial in Blepharitis in 600 participants. Completed in 6 March 2009.

Timeline

2 January 2001

6 March 2009

Quick facts

Lead sponsor	National Eye Institute (NEI)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	600
Start date	2 January 2001
Estimated completion	6 March 2009
Sites	1 location across United States

Conditions studied

• Blepharitis — all drugs for Blepharitis →
• Conjunctivitis — all drugs for Conjunctivitis →
• Corneal Disease — all drugs for Corneal Disease →
• Dacryoadenitis — all drugs for Dacryoadenitis →

Sponsor

National Eye Institute (NEI)

Who can join

2 and older, any sex, with Blepharitis or Conjunctivitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.