Evaluation and Treatment of Patients With Corneal and External Diseases

NCT00008541 | Completed

• 2 other identifiers: 01004601-EI-0046
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

Blepharitis; Conjunctivitis; Corneal Disease; Dacryoadenitis; Dacryocystitis; Keratitis

Keywords

Keratitis; Conjunctivitis; Meibomitis; Corneal Infiltrates; Dacryocystitis; Blepharitis; Dacryoadenitis; Corneal Eye Disease

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Corneal and external diseases or anterior segment disorders.
• If adult, ability to provide informed consent. Cognitively impaired adults will not be enrolled.
• 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.

You may not qualify if:

• Subjects may be excluded if they
• Are unwilling or unable to cooperate with study procedures.
• Have any disease or condition with less than 3 year expected survival.

Sponsors & Collaborators

• National Eye Institute (NEI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Blepharitis; Conjunctivitis; Corneal Diseases; Dacryocystitis; Keratitis; Meibomitis

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases; Conjunctival Diseases; Lacrimal Apparatus Diseases

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: January 13, 2001
• First Posted: January 15, 2001
• Study Start: January 2, 2001
• Study Completion: March 6, 2009
• Last Updated: July 2, 2017

Record last verified: 2009-03-06

Locations

US (1)