Digital Photography to Evaluate Dry Eye

June 30, 2017 updated by: National Eye Institute (NEI)

Digital Image Based Determination of Ocular Surface Vital Dye Staining

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 14, 2003

Study Completion

September 6, 2007

Study Registration Dates

First Submitted

November 14, 2003

First Submitted That Met QC Criteria

November 14, 2003

First Posted (Estimate)

November 17, 2003

Study Record Updates

Last Update Posted (Actual)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 30, 2017

Last Verified

September 6, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 040048
  • 04-EI-0048

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Eye Disease

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