Corneal DiseasesCorneal Scars and OpacitiesCorneal Edema
Investigational drug(s) / intervention(s)
THz scanning using THz Imaging system.
THz scanning using THz Imaging system.: The 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.
Study summary
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
Sex
ALL
Min age
21 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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.
* Patients with corneal endothelial dysfunction (Fuchs' endothelial dystrophy or other causes of bullous keratopathy) at any disease stage OR Patients with corneal scars from any cause, with the absence of corneal edema.
* Ability to hold face sufficiently stable to undergo necessary scans.
Exclusion Criteria:
* Eyes with active inflammation or infection, or chronic ocular surface inflammation
* Unable to give consent
* Physically immobile/poor instructional compliance
* PI determined
* Pregnant/ breast feeding women
Primary outcome measure(s)
National Eye Institute (NEI) Score — Baseline 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.
Central corneal thickness — Baseline Central corneal thickness (CCT) will be assessed using Anterior Segment Optical Coherence Tomography. The CCT will be measured using a build-in caliper software.
Measurements of corneal scars — Baseline 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.
Level of corneal density — Baseline 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.
Extent of keratocytes activation — Baseline In vivo confocal microscopy will be used to capture images of keratocytes. The gray values of reflectivity for corneal stromal scans will be semi-quantified to confirm if there are significant changes in the activity of stromal keratocytes.
Overall appearance of corneas — Baseline External eye photos will be captured to record the status of corneas, showing the location and extent of involvement of the corneal lesion.
Trial sites (1)
Facility
City
Region
Status
Singapore National Eye Centre
Singapore
Singapore
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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