NCT06967792

Brief 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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2024

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 4, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 13, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

May 16, 2025

Status Verified

May 1, 2025

Enrollment Period

1.8 years

First QC Date

May 4, 2025

Last Update Submit

May 13, 2025

Conditions

Corneal Diseases

Keywords

corneacorneal edemaTerahertzhydration

Outcome Measures

Primary Outcomes (1)

  • Level of visual acuity

    Participants will undergo visual acuity assessment including uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) using Snellen chart at every visit. The last line on the chart that subjects are able to read correctly will be selected to calculate the visual acuity.

    1 month

Secondary Outcomes (10)

  • National Eye Institute (NEI) Score

    1 month

  • Extent of anterior chamber (AC) inflammation

    1 month

  • Lens density grade

    1 month

  • Level of anterior chamber (AC) flare

    1 month

  • Level of conjunctival hyperemia

    1 month

  • +5 more secondary outcomes

Study Arms (1)

Blind group

Eyes that are deemed functionally blind but contain healthy corneas.

Device: Terahertz (THz) scanning using THz Imaging system.

Interventions

Terahertz (THz) scanning using THz Imaging system.DEVICE

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.

Blind group

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A total of 5 participants who have unilateral or bilateral functionally blind eyes with normal corneas 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore National Eye Centre

Singapore, Singapore, S169856, Singapore

RECRUITING

MeSH Terms

Conditions

Corneal DiseasesCorneal Edema

Condition Hierarchy (Ancestors)

Eye Diseases

Central Study Contacts

Yu-Chi Liu

CONTACT

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2025

First Posted

May 13, 2025

Study Start

April 1, 2024

Primary Completion

December 31, 2025

Study Completion

April 30, 2026

Last Updated

May 16, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)