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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01933178
Other study ID # R1029/44/2013
Secondary ID 2013/328/A
Status Completed
Phase N/A
First received August 28, 2013
Last updated June 9, 2014
Start date September 2013
Est. completion date February 2014

Study information

Verified date June 2014
Source Singapore National Eye Centre
Contact n/a
Is FDA regulated No
Health authority Singapore: Health Sciences Authority
Study type Interventional

Clinical Trial Summary

Conjunctivochalasis refers to loose redundant, non-edematous inferior conjunctiva that is situated between the globe and lower eyelid, and usually it occurs bilaterally. It has been reported to cause ocular discomfort, tear instability, alteration of tear spreading and subsequently dry eye, which is a common condition that affects vision and quality of life in patients. This condition has also been reported to be associated with aging and ocular surface inflammation.

The assessment of conjunctivochalasis was traditionally based on silt lamp examination and this may be cumbersome and highly subjective. Only recently, researchers have advocated the use of imaging and more objective documentation by anterior segment optical coherence tomography (AS-OCT), using Fourier-Domain RTVue-100 OCT. The AS-OCT is an imaging method that documents the tear meniscus and prolapse of conjunctiva into the tear meniscus in a safe, rapid and non-invasive way. Image analysis on the area of prolapsed conjunctiva can then be used to ascertain the severity of conjunctivochalasis. We propose the use of HD-Cirrus AS-OCT for the imaging of conjunctivochalasis, since this technique provides more magnified and colored digital images, which helps to delineate different tissues and serves as a better education tool for patients.

This current study aims to investigative the inter and intra examiner reproducibility of imaging conjunctivochalasis using HD-Cirrus AS-OCT, using patients from the dry eye clinic from the Singapore National Eye Centre. These patients will be asked to come to the centre for imaging and have three scans of the same eye performed in one session by two trained investigators consecutively. The resulting limits of repeatability will be very useful for us to follow up patients who undergo surgical or diathermy treatment for conjunctivochalasis, and for sample size calculation in the planning of interventional studies.


Description:

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Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Device:
Cirrus AS-OCT


Locations

Country Name City State
Singapore Singapore Eye Research Institute Singapore

Sponsors (1)

Lead Sponsor Collaborator
Singapore National Eye Centre

Country where clinical trial is conducted

Singapore, 

Outcome

Type Measure Description Time frame Safety issue
Primary The repeatabilty of objective conjunctivochalasis measurements of HD-Cirrus AS-OCT from the same examiner, and between the two examiners 1 day No
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