RecruitingNCT06967792

Evaluation of the Safety of Terahertz Scanning System on Corneas

Evaluation of the Safety of Terahertz Scanning System on Corneas: Phase I Trial

Sponsor

Singapore Eye Research Institute

Enrollment

5 participants

Start Date

Apr 1, 2024

Study Type

OBSERVATIONAL

Conditions

Corneal Diseases

Summary

This observational study aims to establish the safety profile of the use of Terahertz (THz) scanning system on corneal diseases. Participants with "non-seeing" eyes but normal corneas will undergo THz scanning. Eye examinations will be conducted at baseline, immediately after scanning, and at 1 day, 1 week, and 1 month post-scanning. These examinations will include measurements of visual acuity, eye structural, retinal health, corneal cell morphology, and corneal nerve status. The investigators hypothesize that the THz scanning system is safe for application to the human cornea.

Eligibility

Min Age: 21 Years

Inclusion Criteria7

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
Have at least 1 eye (Study eye) that is deemed functionally blind but contain healthy corneas
Ability to hold face sufficiently stable to undergo necessary scans
Best Spectacle Corrected Visual Acuity (BSCVA) in the study eye of hand motion or worse

Exclusion Criteria7

Pregnant/Breast-feeding women
Eyes with previous major surgery on the cornea such as corneal transplantation, refractive surgery, corneal cross-linking procedure
Eyes with previous infectious keratitis
Eyes with long-term use of glaucoma eye drops
Eyes with known moderate or server meibomian gland dysfunction
Eyes with active inflammation or infection, or chronic ocular surface inflammation
Systemic diseases that affect the ocular surface, such as systemic autoimmune diseases

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Interventions

DEVICETerahertz (THz) scanning using THz Imaging system.

The Terahertz (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.