Completed

Screening for Research Subjects With Anterior Segment Diseases

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What is being collected

Data Collection

Who is being recruted

Eye Diseases

How is the trial designed

Other

Observational
Study Start: July 2004

Summary

Principal SponsorNational Eye Institute (NEI)
Last updated: July 2, 2017
Sourced from a government-validated database.Claim as a partner
Study start date: July 13, 2004Actual date on which the first participant was enrolled.

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. 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.

Official TitleScreening Study for the Evaluation and Diagnosis of Potential Research Subjects With Anterior Segment Disease 
Principal SponsorNational Eye Institute (NEI)
Last updated: July 2, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
600 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Eye Diseases
Criteria

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



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, United StatesSee the location

CompletedOne Study Center