Screening for Research Subjects With Anterior Segment Diseases

Eye Diseases Clinical Trial

Official title:

Screening Study for the Evaluation and Diagnosis of Potential Research Subjects With Anterior Segment Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00088348
• Other study ID #: 040241
• Secondary ID: 04-EI-0241
• Status: Completed
• Phase: N/A
• First received: July 23, 2004
• Last updated: June 30, 2017
• Start date: July 13, 2004
• Est. completion date: August 20, 2008

Study information

• Verified date: August 20, 2008
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will identify patients with anterior segment disease who may be eligible to participate in current or future NEI studies on this disease. Anterior segment disease includes all disorders that affect the eye surface, anterior chamber, iris and ciliary body and lens of the eye. The eye surface is composed of the cornea, conjunctiva, eyelids, lacrimal and meibomian glands, and the interconnecting nerves.

Patients of any age with anterior segment disease may be eligible for this screening study. Participants will be evaluated with some or all of the following tests and procedures, depending on the nature of their eye problem:

• Medical history and brief physical examination.

• Eye examination, including measurement of visual acuity (eye chart) and eye pressure, examination of the pupils, eye movements, structures in the front of the eye (cornea, conjunctive, etc.), the lens, and the structures in the back of the eye (retinal, optic nerve, etc.).

• Photographs of the eye to help assess the status of the cornea and conjunctive and to evaluate any changes that may occur in the future.

• Assessment of tear and surface status. The amount of tears the eyes can produce is measured by placing a small piece of sterile paper in the corner of the eye every 5 minutes. Special orange and green dyes are placed in the eyes to determine the health status of the surface of the eye.

• Corneal or conjunctival biopsy. A small tissue sample from the surface of the eye may be removed for laboratory examination to help diagnose a condition that is unclear. For this procedure, the eye is numbed with anesthetic eye drops. The required tissue is collected, an antibiotic ointment is placed in the eye to prevent infection, and a patch may be placed over the eye for 12 to 24 hours.

• Blood draw for tests to study the cause of the patient's eye disease.

• Other diagnostic tests as needed.

• DNA testing to look for a genetic pattern associated with the patient's eye disease.

Patients who are found eligible for an NEI study will be offered participation in that study. Patients who are not eligible for current studies will be advised about treatment options.

Description:

This is a screening protocol that will allow the NEI clinicians to examine patients with ocular diseases in order to identify those who may be eligible to participate in other NEI studies on anterior segment disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: August 20, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

• ELIGIBILITY CRITERIA:

To participate in this screening study, a patient must have a history of anterior segment disease. Patients of all ages are eligible.

Related Conditions & MeSH terms

• Eye Diseases

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center, 9000 Rockville Pike	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Holland EJ. Epithelial transplantation for the management of severe ocular surface disease. Trans Am Ophthalmol Soc. 1996;94:677-743. — View Citation