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

This study has been completed.
Sponsor:
Collaborators:
Singapore Eye Research Institute
Nanchang University
Information provided by (Responsible Party):
Louis Tong, Singapore National Eye Centre
ClinicalTrials.gov Identifier:
NCT01479790
First received: October 4, 2011
Last updated: February 20, 2013
Last verified: February 2013
  Purpose

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 Intervention
Dry Eye Syndromes
Device: EyeGiene

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Repeatability and Agreement of Visante and Cirrus Anterior Segment Optical Coherence Tomography and Functional Infrared Thermography

Resource links provided by NLM:


Further study details as provided by Singapore National Eye Centre:

Primary Outcome Measures:
  • equipment repeatability [ Time Frame: 1 day ] [ Designated as safety issue: No ]

    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:
  • temperature changes [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Determine whether thermogram images can capture changes in temperature/the rate of tear evaporation which were introduced by warm eye mask wear.


Enrollment: 40
Study Start Date: June 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01479790

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

Publications:
Responsible Party: Louis Tong, Clinician-Scientist, Consultant, Singapore National Eye Centre
ClinicalTrials.gov Identifier: NCT01479790     History of Changes
Other Study ID Numbers: R845/40/2011, 2011/408/A
Study First Received: October 4, 2011
Last Updated: February 20, 2013
Health Authority: Singapore: Health Sciences Authority

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

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

ClinicalTrials.gov processed this record on October 21, 2014