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Screening for Research Subjects With Anterior Segment Diseases

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00088348
First Posted: July 26, 2004
Last Update Posted: July 2, 2017
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.
Information provided by:
National Institutes of Health Clinical Center (CC)
  Purpose

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.


Condition
Eye Diseases

Study Type: Observational
Official Title: Screening Study for the Evaluation and Diagnosis of Potential Research Subjects With Anterior Segment Disease

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 600
Study Start Date: July 13, 2004
Estimated Study Completion Date: August 20, 2008
Detailed 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.
  Eligibility

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:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00088348


Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Eye Institute (NEI)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00088348     History of Changes
Other Study ID Numbers: 040241
04-EI-0241
First Submitted: July 23, 2004
First Posted: July 26, 2004
Last Update Posted: July 2, 2017
Last Verified: August 20, 2008

Keywords provided by National Institutes of Health Clinical Center (CC):
Cornea
Conjunctiva
Keratitis
Ocular Surface
Inflammation
Evaluation
Screening
Ocular Surface Disease
Eye
Ocular Disease
Anterior Segment Disease

Additional relevant MeSH terms:
Eye Diseases