Repeatability and Agreement of Anterior Segment Optical Coherence Tomography (AS-OCT) and Thermography

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: NCT01479790
Recruitment Status : Completed
First Posted : November 24, 2011
Last Update Posted : February 21, 2013
Singapore Eye Research Institute
Nanchang University
Information provided by (Responsible Party):
Louis Tong, Singapore National Eye Centre

Brief Summary:

Dry eye is a common condition that affects vision and quality of life in patients. Dry eye clinical research is limited to follow up of disease progression. Currently, most research outcomes are based on subjective patient complaints rather than objective assessment of the condition. Only few objective measurements for dry eye are available today and this is mainly the result of poor repeatability and inaccuracy.

This current study aims to evaluate 2 new non-invasive imaging techniques suitable for dry eye assessment.

Anterior segment optical coherence tomography (AS-OCT) is an imaging device that has the ability to image the tear meniscus of the eye in a safe and non-invasive manner. Image analysis can then indirectly determine the tear film volume. Improvements in the image resolution of these devices require a study that compares the repeatability and agreement of an older (Visante AS-OCT) and a newer instrument (Cirrus AS-OCT) which the current study aims to address.

Another method of evaluating dry eye disease is a novel technique that uses functional infrared thermography to measure tear evaporation rate. This study will also establish repeatability of measurements of the ocular surface temperature which are used to calculate tear evaporation rates.

Should these methods are found to be repeatable, they can be used in future clinical trials as an additional tool to investigate dry eye treatments.

Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Device: EyeGiene Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Repeatability and Agreement of Visante and Cirrus Anterior Segment Optical Coherence Tomography and Functional Infrared Thermography
Study Start Date : June 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
No Intervention: Visante AS-OCT and Cirrus AS-OCT
The tear meniscus is the thin concave strip of the tear film near the eyelid margins. During the acquisition the participants place their chins on a chin rest and look at a fixation light/target. This whole procedure should not take more than 5 minutes. The patients are allowed to blink freely except for during the acquisition time of less than 5 seconds. The procedure will be repeated for the upper and lower tear meniscus of both eyes.
Experimental: Thermography measurement

In total, four pairs of thermographic sequences on the ocluar surface temperature from volunteers will be taken.

  1. A thermographic sequence will be captured from each eye.
  2. After 20 minutes, a second pair of thermographic sequences will be captured.
  3. An eye mask with a temperature of not more than 40 deg C (will be worn by the volunteer for 5 minutes and a third pair of thermographic sequences will be captured immediately after mask removal.
  4. A fourth pair of thermographic sequences will be captured 1 hour after mask removal.
Device: EyeGiene
The eye mask with a temperature of not more than 40 deg C (confirmed by thermometer) will be worn by the volunteer for 5 minutes.
Other Name: EyeGiene (Eyedetec Medical Inc., US)

Primary Outcome Measures :
  1. equipment repeatability [ Time Frame: 1 day ]

    Part A - The repeatabilty coefficients of tear meniscus measurements derived from Visante and Cirrus AS-OCT and the agreement between tear meniscus measurements.

    Part B - Infrared thermography is expected to be repeatable in capturing OST measurements which will consequently result in repeatable tear evaporation rates. Temperature changes of the ocular surface will be adequately captured.

Secondary Outcome Measures :
  1. temperature changes [ Time Frame: 1 day ]
    Determine whether thermogram images can capture changes in temperature/the rate of tear evaporation which were introduced by warm eye mask wear.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

- Volunteers that are medically fit and willing to participate in this study.

Exclusion Criteria:

  • No eye surgery done within the previous 3 months
  • Active ocular infection or pterygium that may affect tear film stability.
  • Any other specified reason as determined by clinical investigator.

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): NCT01479790

Singapore Eye Research Institute
Singapore, Singapore, 168751
Sponsors and Collaborators
Singapore National Eye Centre
Singapore Eye Research Institute
Nanchang University
Principal Investigator: Louis Tong, PhD Singapore National Eye Centre

Responsible Party: Louis Tong, Clinician-Scientist, Consultant, Singapore National Eye Centre Identifier: NCT01479790     History of Changes
Other Study ID Numbers: R845/40/2011
2011/408/A ( Other Identifier: SingHealth Centralised Institutional Review Board )
First Posted: November 24, 2011    Key Record Dates
Last Update Posted: February 21, 2013
Last Verified: February 2013

Keywords provided by Louis Tong, Singapore National Eye Centre:
Visante AS-OCT
Cirrus AS-OCT
Tear evaporation
Tear evaporimetry

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Conjunctival Diseases
Corneal Diseases