NCT00088348

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 13, 2004

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 26, 2004

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2008

Completed
Last Updated

July 2, 2017

Status Verified

August 20, 2008

First QC Date

July 23, 2004

Last Update Submit

June 30, 2017

Conditions

Keywords

CorneaConjunctivaKeratitisOcular SurfaceInflammationEvaluationScreeningOcular Surface DiseaseEyeOcular DiseaseAnterior Segment Disease

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
* ELIGIBILITY CRITERIA: To participate in this screening study, a patient must have a history of anterior segment disease. Patients of all ages are eligible.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

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

    PMID: 8981714BACKGROUND

MeSH Terms

Conditions

Eye DiseasesCorneal DiseasesKeratitisInflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

July 23, 2004

First Posted

July 26, 2004

Study Start

July 13, 2004

Study Completion

August 20, 2008

Last Updated

July 2, 2017

Record last verified: 2008-08-20

Locations