Investigating Abnormal Lipid Layer Thickness in Blepharoplasty Patients

NCT ID: NCT01787942

Last Updated: 2014-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-03-31

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

Conditions

Lipid Thickness

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Blepharoplasty

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.

Group Type: ACTIVE_COMPARATOR

Tear Science LipiView

Intervention Type: DEVICE

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.

Control

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.

Group Type: PLACEBO_COMPARATOR

Tear Science LipiView

Intervention Type: DEVICE

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.

Interventions

Tear Science LipiView

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Singapore National Eye Centre

OTHER_GOV

Sponsor Role: lead

Responsible Party

Louis Tong

Clinician-Scientist, Senior Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Louis Tong, Phd

Role: PRINCIPAL_INVESTIGATOR

Singapore National Eye Centre

Locations

Singapore National Eye Centre/ Singapore Eye Research Institute

Singapore, Singapore, Singapore

Countries

Singapore

Other Identifiers

2012/975/A

Identifier Type: OTHER

Identifier Source: secondary_id

R974/83/2012

Identifier Type: -

Identifier Source: org_study_id