RecruitingNCT06983652

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

Validation of the Use of Terahertz Scanning System on Corneal Scars and Corneal Edema: Phase II Clinical Trial

Sponsor

Singapore Eye Research Institute

Enrollment

150 participants

Start Date

Jul 1, 2024

Study Type

OBSERVATIONAL

Conditions

Corneal Diseases Corneal Edema Corneal Scars and Opacities

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

Min Age: 21 Years

Inclusion Criteria6

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 Criteria5

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

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Interventions

DEVICETHz 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.