Lipid ThicknessNCT01787942
Investigating Abnormal Lipid Layer Thickness in Blepharoplasty Patients
A study testing Tear Science LipiView in people with Lipid Thickness, run by Singapore National Eye Centre at 1 site in Singapore.
Trial summary
Deficiency in tear film lipid layer thickness (LLT) has been implicated in the development of dry eye symptoms, and is influenced to a significant degree by the anatomy and function of the eyelids. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Lipid Thickness
- What is being tested?
- Tear Science LipiView
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSingapore
- Study dates
- Jan 2013to Mar 2014
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteers that are medically fit and willing to participate in this study.
- Volunteers who fit the criteria mentioned previously in the experimental design.
Who cannot join
- Patients who are about to undergo cosmetic blepharoplasty.
- Patients with other ocular surgeries pre-blepharoplasty that may have disturbed the ocular surface e.g. cataract phacoemulsification, pterygium removal.
- Patients who experience major post-surgery side effects or complications unrelated to DES will be excluded from the study.
- Patients with history of Parkinson's disease and other neurogenic conditions which interfere with blink rate.
- Patients with proptosis or exophthalmos due to congenital reasons or Thyroid Eye Disease.
- Patients who are on anti-histamine drugs.
Trial locations and contacts
1 site in 1 country.
Singapore1 site
Singapore National Eye Centre/ Singapore Eye Research Institute
Singapore, Singapore, 168751
About this study
Official title: Investigating Abnormal Lipid Layer Thickness and Other Objective Dry Eye Parameters in Patients Seeking Blepharoplasty, and How They Change After Blepharoplasty
Deficiency in tear film lipid layer thickness (LLT) has been implicated in the development of dry eye symptoms, and is influenced to a significant degree by the anatomy and function of the eyelids. Patients who are considering blepharoplasty, even if it is for cosmetic reasons, may subtle differences in eyelid anatomy that pre-dispose them to having an abnormal tear lipid layer. Moreover, the changes in anatomy and contour of the eyelids following blepharoplasty introduce a whole new group of factors, such as an altered palpebral aperture and altered canthal fixation that can further change the eyelid's ability to maintain a healthy tear lipid layer, for better or for worse. Such changes in tear lipid layer can be detected with the aid of a newly acquired tear interferometer (LipiView, Tearscience Inc.), but has never been done in the context of blepharoplasty management. Due to the strong association between LLT and risk of dry eyes, we hope to investigate if there are significant differences in LLT and other objective dry eye parameters in two situations: 1) patients considering blepharoplasty as compared to other patients not considering such procedures 2) patients before and after undergoing blepharoplasty. The results of these investigations can go towards establishing LLT as an important objective parameter to account for before and after blepharoplasty.
Read the detailed description
Study Objectives and Purpose
- By cross-sectional analysis, determine if there are significant differences in average and SD of LLT in a group of patients who are considering blepharoplasty (cases) as compared to a group of patients from a general ophthalmology clinic who have no lid disturbances (controls).
2a. Via a prospective study, determine the average and standard deviation of LLT in a group of patients undergoing blepharoplasty, and how these change in a one month period after surgery.
2b. Identify, through the same prospective study, if factors such as age and gender are associated with the direction and magnitude of changes in LLT.
Study design:
Cross-sectional study and Prospective cohort study
Rationale:
- A cross-sectional study comparing LLT, TBUT and corneal staining in patients who are about to undergo blepharoplasty against patients who have no complaints of any lid disturbances.
- A prospective study observing changes in LLT, TBUT and corneal staining after blepharoplasty, and if age and gender was associated with these changes.
Methods:
30 patients who are about to undergo blepharoplasty will be recruited from the oculoplastic clinic. These patients will form the "case" group of the cross-sectional study, and will be on follow-up for the prospective study.
Another 30 patients will be recruited from the general ophthalmology (ECS) clinic. These patients are cleared to have no lid disturbances in terms of function or anatomy, and will serve as the "control" group of the cross-sectional study.
The following assessments will be performed for each patient who is recruited. For patients involved in the cross-sectional study, they will be assessed only once. For the patients involved in the prospective study, they will be assessed during the pre-surgery consultation, and at the standard post-surgery consultations at 1 week and 1 month after surgery
Procedures to be done
- LLT measurement with LipiView tear interferometer
- Fluorescein Dye Tear Break-up Time (TBUT)
- Fluorescein Dye Corneal Staining
Duration of study: 1 year
- Conditions
- Lipid Thickness
- Being tested
- Tear Science LipiView
- Keywords
- Lipid thickness, Blepharoplasty, Tear break up time, Corneal staining
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tear Science LipiViewDevice
The LipiView is a non-invasive instrument that captures live, special and digital images of your tear film and measures its lipid content and quality. This is a standardized test that quantifies your lipid to help your eye doctor determine if you should undergo the LipiFlow procedure or other tear therapies that would treat your condition. In effect, the LipiView allows your eye doctor to visualize your tear films.
| Study group | Role | What they receive |
|---|---|---|
| Blepharoplasty | Active comparator | Participants under this group will undergo blepharoplasty from the oculoplastic clinic. These patients will form the "case" group of the cross-sectional study, and will be on follow-up for the prospective study. Receives: Device: Tear Science LipiView |
| Control | Placebo comparator | Participants under this group will be recruited from the general ophthalmology clinic. These patients are cleared to have no lid disturbances in terms of function or anatomy, and will serve as the "control" group of the cross-sectional study. Receives: Device: Tear Science LipiView |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid layer thickness
Tear interferometry is non-invasive and is not unlike a standard slit-lamp examination of the eye. Patients will be asked to rest their chin on a chinrest and direct their sight at a single white-light source for 30 seconds. The same process will be repeated for another 30 seconds with the other eye. During this time, they are encouraged to blink at their comfortable pace. It is extremely safe and does not require contact of the ocular surface in any way.
Measured: 1 month
Secondary outcomes (2)
Tear break up time
Fluorescein dye is introduced onto the lower eyelid by a wetted fluorescein strip. The tear film will then be observed with blue light using a slit lamp to the point where it breaks. The time from the previous blink to the breaking of the tear film will be recorded to the nearest second.
Measured: 1 month
Fluorescein Dye Corneal Staining
After fluorescein dye is introduced, the cornea will be examined for green stains indicating epithelial erosion, a sign of damage due to dryness. The number of green stains and their location on the cornea (superior, central, inferior, temporal, nasal fields) will be recorded.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lipid ThicknessStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore National Eye Centre
- Sponsor type
- Other government
- 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
- NCT01787942
- Sponsor's protocol ID
- R974/83/2012
- Other IDs
- 2012/975/A
- Status last verified
- Feb 2013
- First submitted
- 7 Feb 2013
- Last updated
- 19 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Abnormal Lipid Layer Thickness and Other Objective Dry Eye Parameters in Patients Seeking Blepharoplasty, and How They Change After Blepharoplasty
- ClinicalTrials.gov ID
- NCT01787942
- Acronym / sponsor ID
- R974/83/2012
- Conditions
- Lipid Thickness
- Keywords
- Lipid thickness, Blepharoplasty, Tear break up time, Corneal staining
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Singapore National Eye CentreOther government
- Study start
- Jan 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 11 Feb 2013 (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.
Deficiency in tear film lipid layer thickness (LLT) has been implicated in the development of dry eye symptoms, and is influenced to a significant degree by the anatomy and function of the eyelids. Patients who are considering blepharoplasty, even if it is for cosmetic reasons, may subtle differences in eyelid anatomy that pre-dispose them to having an abnormal tear lipid layer. Moreover, the changes in anatomy and contour of the eyelids following blepharoplasty introduce a whole new group of factors, such as an altered palpebral aperture and altered canthal fixation that can further change the eyelid's ability to maintain a healthy tear lipid layer, for better or for worse. Such changes in tear lipid layer can be detected with the aid of a newly acquired tear interferometer (LipiView, Tearscience Inc.), but has never been done in the context of blepharoplasty management. Due to the strong association between LLT and risk of dry eyes, we hope to investigate if there are significant differences in LLT and other objective dry eye parameters in two situations: 1) patients considering blepharoplasty as compared to other patients not considering such procedures 2) patients before and after undergoing blepharoplasty. The results of these investigations can go towards establishing LLT as an important objective parameter to account for before and after blepharoplasty.
Detailed description
Study Objectives and Purpose
- By cross-sectional analysis, determine if there are significant differences in average and SD of LLT in a group of patients who are considering blepharoplasty (cases) as compared to a group of patients from a general ophthalmology clinic who have no lid disturbances (controls).
2a. Via a prospective study, determine the average and standard deviation of LLT in a group of patients undergoing blepharoplasty, and how these change in a one month period after surgery.
2b. Identify, through the same prospective study, if factors such as age and gender are associated with the direction and magnitude of changes in LLT.
Study design:
Cross-sectional study and Prospective cohort study
Rationale:
- A cross-sectional study comparing LLT, TBUT and corneal staining in patients who are about to undergo blepharoplasty against patients who have no complaints of any lid disturbances.
- A prospective study observing changes in LLT, TBUT and corneal staining after blepharoplasty, and if age and gender was associated with these changes.
Methods:
30 patients who are about to undergo blepharoplasty will be recruited from the oculoplastic clinic. These patients will form the "case" group of the cross-sectional study, and will be on follow-up for the prospective study.
Another 30 patients will be recruited from the general ophthalmology (ECS) clinic. These patients are cleared to have no lid disturbances in terms of function or anatomy, and will serve as the "control" group of the cross-sectional study.
The following assessments will be performed for each patient who is recruited. For patients involved in the cross-sectional study, they will be assessed only once. For the patients involved in the prospective study, they will be assessed during the pre-surgery consultation, and at the standard post-surgery consultations at 1 week and 1 month after surgery
Procedures to be done
- LLT measurement with LipiView tear interferometer
- Fluorescein Dye Tear Break-up Time (TBUT)
- Fluorescein Dye Corneal Staining
Duration of study: 1 year
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blepharoplasty | Active comparator | Device: Tear Science LipiViewParticipants under this group will undergo blepharoplasty from the oculoplastic clinic. These patients will form the "case" group of the cross-sectional study, and will be on follow-up for the prospective study. |
| Control | Placebo comparator | Device: Tear Science LipiViewParticipants under this group will be recruited from the general ophthalmology clinic. These patients are cleared to have no lid disturbances in terms of function or anatomy, and will serve as the "control" group of the cross-sectional study. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Volunteers that are medically fit and willing to participate in this study.
- Volunteers who fit the criteria mentioned previously in the experimental design.
Key exclusion criteria (6 listed)
- Patients who are about to undergo cosmetic blepharoplasty.
- Patients with other ocular surgeries pre-blepharoplasty that may have disturbed the ocular surface e.g. cataract phacoemulsification, pterygium removal.
- Patients who experience major post-surgery side effects or complications unrelated to DES will be excluded from the study.
- Patients with history of Parkinson's disease and other neurogenic conditions which interfere with blink rate.
- Patients with proptosis or exophthalmos due to congenital reasons or Thyroid Eye Disease.
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 |
|---|---|---|
| Tear Science LipiViewThe LipiView is a non-invasive instrument that captures live, special and digital images of your tear film and measures its lipid content and quality. This is a standardized test that quantifies your lipid to help your eye doctor determine if you should undergo the LipiFlow procedure or other tear therapies that would treat your condition. In effect, the LipiView allows your eye doctor to visualize your tear films. | Device | Blepharoplasty, Control |
Primary outcome
Lipid layer thickness
Time frame: 1 month
Tear interferometry is non-invasive and is not unlike a standard slit-lamp examination of the eye. Patients will be asked to rest their chin on a chinrest and direct their sight at a single white-light source for 30 seconds. The same process will be repeated for another 30 seconds with the other eye. During this time, they are encouraged to blink at their comfortable pace. It is extremely safe and does not require contact of the ocular surface in any way.
2 secondary outcomes
Tear break up time
Time frame: 1 month
Fluorescein Dye Corneal Staining
Time frame: 1 month
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 19 Aug 2014.
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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 Tear Science LipiView in people with Lipid Thickness, 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 2 inclusion and 6 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 19 Aug 2014. 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. Some participants in this study may receive a placebo. 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?
Lipid layer thickness (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2014.