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

NCT01479790 | Completed

• 2 other identifiers: R845/40/20112011/408/A
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye Syndromes

Keywords

Visante AS-OCT; Cirrus AS-OCT; Thermography; Tear evaporation; Tear evaporimetry

Outcome Measures

Primary Outcomes (1)

• equipment repeatability

  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.

  1 day

Secondary Outcomes (1)

• temperature changes

  1 day

Study Arms (2)

Visante AS-OCT and Cirrus AS-OCT

NO INTERVENTION

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.

Thermography measurement

EXPERIMENTAL

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

Interventions

EyeGiene DEVICE

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.

Also known as: EyeGiene (Eyedetec Medical Inc., US)

Thermography measurement

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Singapore National Eye Centre: lead
• Singapore Eye Research Institute: collaborator
• Nanchang University: collaborator

Study Sites (1)

Singapore Eye Research Institute

Singapore, Singapore, 168751, Singapore

Location

Related Publications (2)

• Tan JH, Ng EY, Acharya UR. Evaluation of tear evaporation from ocular surface by functional infrared thermography. Med Phys. 2010 Nov;37(11):6022-34. doi: 10.1118/1.3495540.

  PMID: 21158314 BACKGROUND

• Savini G, Goto E, Carbonelli M, Barboni P, Huang D. Agreement between stratus and visante optical coherence tomography systems in tear meniscus measurements. Cornea. 2009 Feb;28(2):148-51. doi: 10.1097/ICO.0b013e31818526d0.

  PMID: 19158555 BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Louis Tong, PhD

  Singapore National Eye Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician-Scientist, Consultant

Study Record Dates

• First Submitted: October 4, 2011
• First Posted: November 24, 2011
• Study Start: June 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 21, 2013

Record last verified: 2013-02

Locations

SG (1)