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Digital Photography to Evaluate Dry Eye

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00073099
Recruitment Status : Completed
First Posted : November 17, 2003
Last Update Posted : July 2, 2017
Information provided by:
National Institutes of Health Clinical Center (CC)

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.

Condition or disease
Eye Disease

Detailed Description:
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.

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Study Type : Observational
Enrollment : 60 participants
Official Title: Digital Image Based Determination of Ocular Surface Vital Dye Staining
Study Start Date : November 14, 2003
Study Completion Date : September 6, 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.


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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00073099

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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Eye Institute (NEI)
Layout table for additonal information Identifier: NCT00073099    
Other Study ID Numbers: 040048
First Posted: November 17, 2003    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: September 6, 2007
Keywords provided by National Institutes of Health Clinical Center (CC):
Dry Eye
Lissamine Green
Digital Photography
Corneal and Conjunctival Staining
Additional relevant MeSH terms:
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Eye Diseases