Dry Eye SyndromesNCT01479790
Repeatability and Agreement of Anterior Segment Optical Coherence Tomography (AS-OCT) and Thermography
A study testing EyeGiene in people with Dry Eye Syndromes, run by Singapore National Eye Centre at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- EyeGiene
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSingapore
- Study dates
- Jun 2011to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteers that are medically fit and willing to participate in this study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Singapore1 site
Singapore Eye Research Institute
Singapore, Singapore, 168751
About this study
Official title: Repeatability and Agreement of Visante and Cirrus Anterior Segment Optical Coherence Tomography and Functional Infrared Thermography
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.
Read more
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.
Read the detailed description
Study Objectives and Purpose:
Part A - AS-OCT repeatability and agreement
- The primary purpose of Part A is to compare the repeatability of the Cirrus with the Visante AS-OCT imaging system.
- The second objective is to identify the level of agreement in the tear meniscus measurements taken by the Cirrus and Visante AS-OCT.
Part B - Tear evaporimetry with functional infra-red thermography
- To evaluate the repeatability of Infrared thermography for ocular surface temperature measurements that are used for calculation of tear evaporation rates. If this is found to be acceptable, it will be correlated to tear meniscus parameters.
- To determine whether this method is able to detect temperature changes of the ocular surface.
Study design:
Part A. Cross sectional study. Part B. Prospective study
Rationale:
Part A - AS-OCT repeatability and agreement Repeatability is an important issue in the objective assessment of dry eye. While previous studies have compared various methods of measuring the tear meniscus, including the use of Visante AS-OCT, current literature lacks studies that investigated the Cirrus AS-OCT for assessment of dry eye. With a higher resolution, the Cirrus is potentially useful as a non-invasive procedure for objective measurements of the tear meniscus.
Part B - Tear evaporimetry with functional infra-red thermography Current available methods to measure of tear evaporation rate have major limitations. This new method, however, is non-invasive, has no need for special eye drops or chambers and takes temperature measurements very quickly. This method is therefore extremely practical and provides many exciting possibilities for future trials.
Methods:
Participants and target sample size 40 volunteers from Singapore Eye Research Institute will be recruited for this study. Each volunteer will be given a study serial number to ensure anonymity.
20 will participate in the AS-OCT study. 20 will participate in the tear evaporimetry study.
Part A - AS-OCT repeatability and agreement Two AS-OCT imaging systems, namely Cirrus and the Visante, will be tested. All participants undergo acquisition of 2 images by the Visante AS-OCT, then 2 images by the Cirrus AS-OCT. Both images will be acquired by the same technician.
Part B - Tear evaporimetry with functional infra-red thermography In total, four pairs of thermographic sequences on the ocluar surface temperature from volunteers will be taken.
- The volunteer will be seated in front of the thermographic camera and on each eye on thermographic sequence will be captured.
- After 20 minutes, a second pair of thermographic sequences will be captured.
- An eye mask with a temperature of not more than 40 deg C (confirmed by thermometer) will be worn by the volunteer for 5 minutes.
- A third pair of thermographic sequences will be captured immediately after mask removal.
- A fourth pair of thermographic sequences will be captured 1 hour after mask removal.
Between sequence acquisitions, the volunteer is allowed to move freely in the room. The temperature and humidity of the room will be kept constant during measurements.
Visit schedules:
Only one examination per ASOCT instrument for Part A is required. For Part B, all thermography will be performed on the same day.
If participants agree to have both ASOCT and tear evaporimetry done, then they will undergo Parts A and B. If not, they will be recruited for either Part A or Part B.
Duration of study: 1 day
- Conditions
- Dry Eye Syndromes
- Being tested
- EyeGiene
- Keywords
- Visante AS-OCT, Cirrus AS-OCT, Thermography, Tear evaporation, Tear evaporimetry
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EyeGieneDevice
Also called EyeGiene (Eyedetec Medical Inc., US)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: EyeGiene |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (1)
temperature changes
Determine whether thermogram images can capture changes in temperature/the rate of tear evaporation which were introduced by warm eye mask wear.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2011 (estimated)
- Study startJun 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore National Eye Centre
- Sponsor type
- Other government
- Collaborators
- Singapore Eye Research Institute, Nanchang University
- Responsible party
- Principal investigator, Louis Tong, Singapore National Eye Centre
- Investigators
- Louis Tong, PhD, Principal investigator, Singapore National Eye Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01479790
- Sponsor's protocol ID
- R845/40/2011
- Other IDs
- 2011/408/A
- Status last verified
- Feb 2013
- First submitted
- 4 Oct 2011
- Last updated
- 21 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21158314Savini 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.
PubMed 19158555
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeatability and Agreement of Visante and Cirrus Anterior Segment Optical Coherence Tomography and Functional Infrared Thermography
- ClinicalTrials.gov ID
- NCT01479790
- Acronym / sponsor ID
- R845/40/2011
- Conditions
- Dry Eye Syndromes
- Keywords
- Visante AS-OCT, Cirrus AS-OCT, Thermography, Tear evaporation, Tear evaporimetry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Singapore National Eye CentreOther government
- Collaborators
- Singapore Eye Research Institute, Nanchang University
- Study start
- Jun 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 24 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Objectives and Purpose:
Part A - AS-OCT repeatability and agreement
- The primary purpose of Part A is to compare the repeatability of the Cirrus with the Visante AS-OCT imaging system.
- The second objective is to identify the level of agreement in the tear meniscus measurements taken by the Cirrus and Visante AS-OCT.
Part B - Tear evaporimetry with functional infra-red thermography
- To evaluate the repeatability of Infrared thermography for ocular surface temperature measurements that are used for calculation of tear evaporation rates. If this is found to be acceptable, it will be correlated to tear meniscus parameters.
- To determine whether this method is able to detect temperature changes of the ocular surface.
Study design:
Part A. Cross sectional study. Part B. Prospective study
Rationale:
Part A - AS-OCT repeatability and agreement Repeatability is an important issue in the objective assessment of dry eye. While previous studies have compared various methods of measuring the tear meniscus, including the use of Visante AS-OCT, current literature lacks studies that investigated the Cirrus AS-OCT for assessment of dry eye. With a higher resolution, the Cirrus is potentially useful as a non-invasive procedure for objective measurements of the tear meniscus.
Part B - Tear evaporimetry with functional infra-red thermography Current available methods to measure of tear evaporation rate have major limitations. This new method, however, is non-invasive, has no need for special eye drops or chambers and takes temperature measurements very quickly. This method is therefore extremely practical and provides many exciting possibilities for future trials.
Methods:
Participants and target sample size 40 volunteers from Singapore Eye Research Institute will be recruited for this study. Each volunteer will be given a study serial number to ensure anonymity.
20 will participate in the AS-OCT study. 20 will participate in the tear evaporimetry study.
Part A - AS-OCT repeatability and agreement Two AS-OCT imaging systems, namely Cirrus and the Visante, will be tested. All participants undergo acquisition of 2 images by the Visante AS-OCT, then 2 images by the Cirrus AS-OCT. Both images will be acquired by the same technician.
Part B - Tear evaporimetry with functional infra-red thermography In total, four pairs of thermographic sequences on the ocluar surface temperature from volunteers will be taken.
- The volunteer will be seated in front of the thermographic camera and on each eye on thermographic sequence will be captured.
- After 20 minutes, a second pair of thermographic sequences will be captured.
- An eye mask with a temperature of not more than 40 deg C (confirmed by thermometer) will be worn by the volunteer for 5 minutes.
- A third pair of thermographic sequences will be captured immediately after mask removal.
- A fourth pair of thermographic sequences will be captured 1 hour after mask removal.
Between sequence acquisitions, the volunteer is allowed to move freely in the room. The temperature and humidity of the room will be kept constant during measurements.
Visit schedules:
Only one examination per ASOCT instrument for Part A is required. For Part B, all thermography will be performed on the same day.
If participants agree to have both ASOCT and tear evaporimetry done, then they will undergo Parts A and B. If not, they will be recruited for either Part A or Part B.
Duration of study: 1 day
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: EyeGieneIn 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. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Volunteers that are medically fit and willing to participate in this study.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EyeGieneAlso: EyeGiene (Eyedetec Medical Inc., US)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. | Device | Thermography measurement |
Primary outcome
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.
1 secondary outcome
temperature changes
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2013.
- Background: PubMed 21158314Tan 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.
- Background: PubMed 19158555Savini 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louis Tong, PhD principal investigator
Singapore National Eye Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EyeGiene in people with Dry Eye Syndromes, run by Singapore National Eye Centre at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
equipment repeatability (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01479790, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2013.