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
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.
Ocular surface vital dye staining is a measure of ocular surface damage and is frequently
used as an endpoint in clinical studies. The identification and development of standardized
objective outcome measures for the evaluation of therapeutic intervention of ocular surface
disease is an area previously identified as critical to the future of well-designed clinical
trials in this area. The Report of the NEI / Industry Workshop on Clinical Trials in Dry
Eyes identified, the standardization of clinical tests used to diagnose dry eye states and
assess treatment effects, as an area of critical interest. The purpose of this protocol is
to determine the suitability of slit lamp biomicroscopic digital photography of ocular
surface vital dye staining by comparing it to the current standard procedure, clinical
assessment. Digital image-based assessment would have many advantages over current
procedures and would apply the appropriate rigor to the evaluation of the anterior segment
that has been shown to be an extremely effective method for the evaluation of the extent of
posterior segment diseases such as diabetic retinopathy and age-related macular
degeneration. Such valid, reproducible, reliable photographic documentation of retinal
abnormalities and disease progression has been successfully employed as a primary outcome
measure in many large clinical trials. In this protocol, we will compare grading of digital
images of ocular surface staining to clinical assessment, facilitating the use of ocular
surface vital dye staining as a valid outcome measure in clinical trials.
- INCLUSION CRITERIA:
Individuals with ocular surface dysfunction and/or disease are eligible for inclusion in
Individuals being evaluated or treated for ocular surface disease will be enrolled.
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.