NCT01787942|Completed
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Sponsor study identifier
Secondary identifiers
OTHER · Singhealth Centralised Institutional Review Board
interventional
60
1 country
1
Study Start
January 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2014
Actual (reported)Study Completion
March 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2013
Date type not reportedThis date has not been verified as actual or estimated.
February 7, 2013
Actual (reported)February 11, 2013
Actual (reported)March 2014
Actual (reported)March 2014
Actual (reported)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.
1 month
Tear break up time
1 month
Fluorescein Dye Corneal Staining
1 month
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.
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Singapore National Eye Centre/ Singapore Eye Research Institute
Singapore, Singapore, 168751, Singapore
Louis Tong, Phd
Singapore National Eye Centre
60 participants (actual enrollment reported by the registry).
First Submitted
February 7, 2013
First Posted
February 11, 2013
Study Start
January 2013
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
March 2014
Actual (reported)Study Completion
March 2014
Actual (reported)Last Updated
August 19, 2014
Record last verified: 2013-02
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Source: ClinicalTrials.gov.
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