Digital Photography to Evaluate Dry Eye

NCT00073099 | Completed

• 2 other identifiers: 04004804-EI-0048
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Eye Disease

Keywords

Dry Eye; Lissamine Green; Fluorescein; Conjunctiva; Cornea; Digital Photography; Corneal and Conjunctival Staining

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Eye Institute (NEI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• Kim J. The use of vital dyes in corneal disease. Curr Opin Ophthalmol. 2000 Aug;11(4):241-7. doi: 10.1097/00055735-200008000-00005.

  PMID: 10977768 BACKGROUND

MeSH Terms

Conditions

Eye Diseases; Dry Eye Syndromes; Corneal Diseases

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 14, 2003
• First Posted: November 17, 2003
• Study Start: November 14, 2003
• Study Completion: September 6, 2007
• Last Updated: July 2, 2017

Record last verified: 2007-09-06

Locations

US (1)