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Tear Layer Lipid Thickness in Pterygium Patient Before and After Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02160769
Recruitment Status : Completed
First Posted : June 11, 2014
Last Update Posted : October 22, 2020
Information provided by (Responsible Party):
Louis Tong, Singapore National Eye Centre

Brief Summary:

The investigators study aims to capture the objective effects of pterygium surgery on tear layer lipid thickness and the tear layer.

Previous objective studies of the tear film has been limited to corneal staining grading, tear break up time and Schirmer's test which have been shown to poor to moderate repeatability. The effect of pterygiums on tear layer lipid thickness (LLT) has not previously been explored. With the LipiView Ocular Surface Interferometer, the investigators have the ability to assess the optical coherence interference pattern produced by light reflected off the tear film in a safe and non-invasive manner. Software analysis of the image then measures the tear LLT which can be used to objectively quantify the diagnosis of lipid-deficient dry eye.

Condition or disease
Dry Eye

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Study Type : Observational
Actual Enrollment : 76 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Assessment of Tear Layer and Tear Layer Lipid Distribution Pre and 1 Month Post Pterygium Surgery Using a LipiView Ocular Surface Interferometer (LipiView)
Actual Study Start Date : November 2013
Actual Primary Completion Date : July 2020
Actual Study Completion Date : July 2020

Primary Outcome Measures :
  1. tear lipid layer thickness [ Time Frame: 1 month ]
    An increase in tear lipid layer thickness 1 month post pterygium surgery in the operated eye

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy normal volunteers and Pterygium patients undergoing surgery to remove Pterygium

Inclusion Criteria:

  • Normal controls or patients with pterygium who have consented for pterygium surgery and are willing to participate in this study

Exclusion Criteria:

  • Active ocular surface conditions such as infections.
  • Any other specified reason as determined by clinical investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02160769

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Singapore Eye Research Institute
Singapore, Singapore., Singapore, 168751
Sponsors and Collaborators
Singapore National Eye Centre
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Responsible Party: Louis Tong, Clinician-Scientist, Senior Consultant, Singapore National Eye Centre Identifier: NCT02160769    
Other Study ID Numbers: R1075/90/2013
2013/851/A ( Other Identifier: SingHealth Centralised Institutional Review Board )
First Posted: June 11, 2014    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Keywords provided by Louis Tong, Singapore National Eye Centre:
Tear Lipid Thickness
Pterygium surgery
Additional relevant MeSH terms:
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Conjunctival Diseases
Eye Diseases