Clinical trial NCT01787942: Investigating Abnormal Lipid Layer Thickness in Blepharoplasty Patients
Official title: Investigating Abnormal Lipid Layer Thickness and Other Objective Dry Eye Parameters in Patients Seeking Blepharoplasty, and How They Change After Blepharoplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lipid Thickness
Keywords: Lipid thickness
Blepharoplasty
Tear break up time
Corneal staining
Lead sponsor: Singapore National Eye Centre
Sponsor class: OTHER_GOV
First posted: 2013-02-11
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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

Eligibility criteria: Inclusion Criteria:

1. Volunteers that are medically fit and willing to participate in this study.
2. Volunteers who fit the criteria mentioned previously in the experimental design.

Exclusion Criteria:

1. Patients who are about to undergo cosmetic blepharoplasty.
2. Patients with other ocular surgeries pre-blepharoplasty that may have disturbed the ocular surface e.g. cataract phacoemulsification, pterygium removal.
3. Patients who experience major post-surgery side effects or complications unrelated to DES will be excluded from the study.
4. Patients with history of Parkinson's disease and other neurogenic conditions which interfere with blink rate.
5. Patients with proptosis or exophthalmos due to congenital reasons or Thyroid Eye Disease.
6. Patients who are on anti-histamine drugs.

Primary outcomes:
measure: Lipid layer thickness
timeFrame: 1 month
Secondary outcomes:
measure: Tear break up time
timeFrame: 1 month
measure: Fluorescein Dye Corneal Staining
timeFrame: 1 month
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore National Eye Centre/ Singapore Eye Research Institute
Study officials:
affiliation: Singapore National Eye Centre
name: Louis Tong, Phd
role: PRINCIPAL_INVESTIGATOR
References: