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Tear Layer Lipid Thickness in Pterygium Patient Before and After Surgery

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ClinicalTrials.gov Identifier: NCT02160769
Recruitment Status : Recruiting
First Posted : June 11, 2014
Last Update Posted : April 18, 2018
Sponsor:
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

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 80 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)
Study Start Date : November 2013
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears




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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02160769


Contacts
Contact: Cynthia Boo, Bsc 9820 6648 cynthia.boo.s.k@seri.com.sg

Locations
Singapore
Singapore Eye Research Institute Recruiting
Singapore, Singapore., Singapore, 168751
Contact: Cynthia Boo    98206648    cynthia.boo.s.k@seri.com.sg   
Principal Investigator: Louis Tong, PhD         
Sponsors and Collaborators
Singapore National Eye Centre

Responsible Party: Louis Tong, Clinician-Scientist, Senior Consultant, Singapore National Eye Centre
ClinicalTrials.gov Identifier: NCT02160769     History of Changes
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: April 18, 2018
Last Verified: October 2016

Keywords provided by Louis Tong, Singapore National Eye Centre:
Tear Lipid Thickness
Pterygium surgery

Additional relevant MeSH terms:
Pterygium
Conjunctival Diseases
Eye Diseases