Investigating Abnormal Lipid Layer Thickness in Blepharoplasty Patients
Condition: Lipid Thickness
Study type: Interventional

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. 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

      1. 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:

        1. 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.

        2. 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

        1. LLT measurement with LipiView tear interferometer

        2. Fluorescein Dye Tear Break-up Time (TBUT)

        3. Fluorescein Dye Corneal Staining

      Duration of study: 1 year
    

Intervention name(s): Tear Science LipiView
Intervention type(s): Device
Intervention description(s): 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.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Lipid thickness; Blepharoplasty; Tear break up time; Corneal staining