Screening for Research Subjects With Anterior Segment Diseases

Sponsor
National Eye Institute (NEI) (NIH)
Overall Status
Completed
CT.gov ID
NCT00088348
Collaborator
(none)
600
1
49.2
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Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Official Title:
    Screening Study for the Evaluation and Diagnosis of Potential Research Subjects With Anterior Segment Disease
    Study Start Date :
    Jul 13, 2004
    Study Completion Date :
    Aug 20, 2008

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      N/A and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      • 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

      Locations

      Site City State Country Postal Code
      1 National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda Maryland United States 20892

      Sponsors and Collaborators

      • National Eye Institute (NEI)

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00088348
      Other Study ID Numbers:
      • 040241
      • 04-EI-0241
      First Posted:
      Jul 26, 2004
      Last Update Posted:
      Jul 2, 2017
      Last Verified:
      Aug 20, 2008

      Study Results

      No Results Posted as of Jul 2, 2017