Validation of the Use of Terahertz Scanning System on Corneal Scars and Corneal Edema

NCT06983652 | Recruiting

• 1 other identifier: 2024-3286
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Corneal Diseases; Corneal Scars and Opacities; Corneal Edema

Keywords

cornea; corneal scar; corneal edema; Terahertz; hydration

Outcome Measures

Primary Outcomes (6)

• 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.

  Baseline

• 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.

  Baseline

• 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.

  Baseline

• 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.

  Baseline

• Extent of keratocytes activation

  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.

  Baseline

• Overall appearance of corneas

  External eye photos will be captured to record the status of corneas, showing the location and extent of involvement of the corneal lesion.

  Baseline

Study Arms (2)

Corneal edema cohort

Patients with corneal endothelial dysfunction (Fuchs' endothelial dystrophy or other causes of bullous keratopathy) at any disease stage, with manifestation of corneal edema.

Device: THz scanning using THz Imaging system.

Corneal scar cohort

Patients with corneal scars from any cause, with the absence of corneal edema.

Device: THz scanning using THz Imaging system.

Interventions

THz scanning using THz Imaging system. DEVICE

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.

Corneal edema cohort; Corneal scar cohort

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 150 participants with corneal diseases, including corneal scars and corneal edema, will be recruited from Singapore National Eye Centre.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Singapore Eye Research Institute: lead

Study Sites (1)

Singapore National Eye Centre

Singapore, S169856, Singapore

RECRUITING

MeSH Terms

Conditions

Corneal Diseases; Corneal Injuries; Corneal Edema

Condition Hierarchy (Ancestors)

Eye Diseases; Eye Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries

Central Study Contacts

Yu-Chi Liu, MD, MCI, PhD

CONTACT

65 65767287; liu.yu.chi@snec.com.sg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 21, 2025
• Study Start: July 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)