Validation of the Use of Terahertz Scanning System on Corneal Scars and Corneal Edema
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21+
SponsorSingapore Eye Research Institute
About this trial
This observational study aims to validate the use of THz scanning system in corneal edema and corneal scars, and to investigate the accuracy and performance on the use of THz scanning system in the evaluation of the progression of corneal edema and corneal scars. Participants corneal scars and corneal edema will undergo THz scanning, followed by a series of conventional clinical examinations for detailed characterization of the corneal lesion. The performance of the use of THz system on corneal scars and edema will be evaluated by correlating measurements from the THz scans with those obtained from standard clinical methods. The investigators hypothesize that the THz scanning system has the capacity to evaluate the hydration level on human corneas.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Be at least 21 years of age.
Regardless of gender (Male/Female).
Regardless of race (Chinese/Malay/Indian/Eurasian/Others).
Willingness and ability to follow all instructions and comply with study schedule for study visit.
Disqualifiers
Eyes with active inflammation or infection, or chronic ocular surface inflammation
Unable to give consent
Physically immobile/poor instructional compliance
PI determined
Trial population
A total of 150 participants with corneal diseases, including corneal scars and corneal edema, will be recruited from Singapore National Eye Centre.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
THz scanning using THz Imaging system.
DeviceThe THz scanning system is non-invasive and non-contact. It is a prototype developed by Institute of Materials Research and Engineering (IMRE), A\*STAR, Singapore and is performed for the purpose of research. THz scanning will provide safety data in human and the measurement of cornea hydration status. Each THz scan will take approximately 1 second. Real-time data will be generated when participants are positioned in front of the device.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Corneal edema cohort1 intervention
Group B: Corneal scar cohort1 intervention
Trial outcomes
Primary outcomes
1
National Eye Institute (NEI) Score
The cornea will be divided into five regions, each scored ranging from 0 (no fluorescein staining) to 3 (severe fluorescein staining) according to the grading scheme. The total NEI score will range from 0 to 15.
Time frame
Baseline2
Central corneal thickness
Central corneal thickness (CCT) will be assessed using Anterior Segment Optical Coherence Tomography. The CCT will be measured using a build-in caliper software.
Time frame
Baseline3
Measurements of corneal scars
Segment Optical Coherence Tomography will be used to perform 1x corneal cross line scan, and 3x 3D cornea scans to obtain detailed measurements of the corneal scars. All scans will be taken en-face.
Time frame
Baseline4
Level of corneal density
Corneal densitometry will be performed using the rotating Scheimpflug anterior segment analyzer. All parameters will be automatically calculated by the in-built software and densitometry measurements will be expressed in standardized greyscale units.
Time frame
BaselineSponsors and contacts
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Source ClinicalTrials.gov