NIH Clinical Research Studies

Protocol Number: 04-EI-0048

Active Accrual, Protocols Recruiting New Patients

Title:
Digital Image Based Determination of Ocular Surface Vital Dye Staining
Number:
04-EI-0048
Summary:
Surface eye problems (problems of the cornea and conjunctiva), such as dry eye, are often evaluated using ocular surface staining - the application of a colored dye to the surface of the eye. The physician examines the nature, degree, and pattern of staining on the eye's surface to determine the diagnosis, assess disease severity, and document treatment effects. Grading of ocular surface staining is often used in research studies to measure the response to a treatment or treatment side effects. Therefore, it is critical that the grading methodology be reproducible and sufficiently detailed to detect changes in eye health status. Current evaluation techniques using these dyes are somewhat subjective, however, since they require human assessment and judgment. This study will assess the validity and reliability of digital photography and compare it with standard slit lamp evaluation for analyzing ocular surface dye staining to document surface eye damage in patients with dry eye.

Patients 3 years of age and older with dry eye may be eligible for this study. Participants will have the following tests and procedures:

- Visual acuity: (eye chart) test

- Slit lamp evaluation: Examination of the front part of the eye with a special microscope called a slit lamp biomicroscope. Special dyes derived from vegetables are instilled into the eye to stain the surface of the eye where it is dry and damaged. The doctor then determines the extent of staining. The staining will be repeated within one week of the first examination.

- Digital eye photography: Digital photographs of the eye are taken to aid in assessing the extent of dry eye changes. The camera flashes a bright light for each picture. About 5 to 10 pictures are taken for each eye.

Sponsoring Institute:
National Eye Institute (NEI)
Recruitment Detail
Type: Active Accrual Of New Subjects
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): None

Eligibility Criteria:
INCLUSION CRITERIA:

Individuals with ocular surface dysfunction and/or disease are eligible for inclusion in this study.

Individuals being evaluated or treated for ocular surface disease will be enrolled.

EXCLUSION CRITERIA:

Patients who cannot hold their eyes open long enough for the photographs to be taken or who has a known allergy to sodium fluorescein or lissamine green will be excluded.

Children 2 years of age or younger will be excluded since they will not be able to cooperate for slit lamp photography. Dry eye is exceedingly uncommon in this age group.

Special Instructions: Currently Not Provided
Keywords:
Dry Eye
Lissamine Green
Fluorescein
Conjunctiva
Cornea
Digital Photography
Corneal and Conjunctival Staining
Recruitment Keywords:
None
Conditions:
Eye Disease
Investigational Drug(s):
None
Investigational Device(s):
None

Contacts:
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:
Manning FJ, Wehrly SR, Foulks GN. Patient tolerance and ocular surface staining characteristics of lissamine green versus rose bengal. Ophthalmology. 1995 Dec;102(12):1953-7.

Kim J, Foulks GN. Evaluation of the effect of lissamine green and rose bengal on human corneal epithelial cells. Cornea. 1999 May;18(3):328-32.

Kim J. The use of vital dyes in corneal disease. Curr Opin Ophthalmol. 2000 Aug;11(4):241-7. Review.

Active Accrual, Protocols Recruiting New Patients

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