Validating the Diagnostic Accuracy of Mediview 2.0 Software as an Image Analysis Tool of Meibomian Glands
2 other identifiers
interventional
100
1 country
1
Brief Summary
Non-contact meibography is a useful tool in assessing the health of meibomian glands in patients. Instead of using normal light in contact meibography, non-contact meibography utilises infra-red (IR) light. IR light is shined on patients' inverted eyelids and a special camera then allows visualisation of the structure of the meibomian glands, including the ducts and acini. Currently, images taken via non-contact meibography are manually analysed by a skilled clinician. Knowledge of the health of meibomian glands is useful, especially in the diagnosis of Meibomian Gland Dysfunction (MGD). Studies have shown that MGD is one of the most common causes of evaporative dry eye. Mediview 2.0 is a software that has been programmed to semi-automatically classify meibograph images taken via non-contact meibography. This software is collaboration with Shanghai MediWorks Precision Instruments Co., Ltd. The algorithm used was developed by a collaboration between Agency for Science, Technology and Research (A\*STAR) and Singapore Eye Research Institute (SERI). This current study aims to validate the diagnostic accuracy of Mediview 2.0 in assessing the health of meibomian glands of patients, against a trained clinician. We aim to recruit 100 participants for this study. Once this software is found to be valid, a trained technician could be taught how to capture the images and hence leaving the doctors with more time to focus on clinical assessment and treatment instead. Therefore, this study has the potential to increase efficiency in the clinics.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 11, 2013
CompletedFirst Posted
Study publicly available on registry
November 25, 2013
CompletedStudy Start
First participant enrolled
December 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedMay 20, 2015
June 1, 2014
1 year
November 11, 2013
May 18, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To certify the accuracy of the software
To validate the accuracy of Mediview 2.0 in classifying meibograph images (into Healthy and Unhealthy categories) and reproducibility of the classifications.
1 day
Study Arms (1)
MediView 2.0 software
OTHERInterventions
Eligibility Criteria
You may qualify if:
- Healthy volunteers/ patients that are willing to participate in this study.
You may not qualify if:
- Any other specified reason as determined by clinical investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Singapore Eye Research Institute
Singapore, Singapore, 168751, Singapore
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Louis Tong, PhD
Singapore National Eye Centre
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinician-Scientist, Senior Consultant
Study Record Dates
First Submitted
November 11, 2013
First Posted
November 25, 2013
Study Start
December 1, 2013
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
May 20, 2015
Record last verified: 2014-06