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Corneal DiseasesNCT06967792

Evaluation of the Safety of Terahertz Scanning System on Corneas

An observational study of Corneal Diseases, run by Singapore Eye Research Institute at 1 site in Singapore.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Corneal Diseases
What is being tested?
Terahertz (THz) scanning using THz Imaging system.
Type of treatment
Medical device
How many people
5 participants
Where
1 siteSingapore
Study dates
1 Apr 2024to 30 Apr 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Singapore1 site, 1 recruiting
  • Singapore National Eye Centre

    Singapore, Singapore, S169856

    Yu-Chi Liu, MD, MCI, PhD, 65 65767287, liu.yu.chi@snec.com.sg

    Recruiting

Other trials in Singapore

About this study

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

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.

Read the detailed description

Corneal disease is the second leading cause on irreversible blindness in the world. There are more than 250 million people living with visual acuity loss or blindness globally. The cornea is a transparent and avascular tissue that consists of 78% water by volume. With its high-water content, the homogeneity of corneal stromal tissue and the lack of physiological variations allows Terahertz (THz) imaging to be a promising method for sensing corneal hydration level as it is highly sensitive to water. The water content of the cornea is regulated by passive and active mechanism to ensure the preservation of essential transmission and focusing properties. When there is an abnormal elevation of water concentration in the cornea (>5% above the physiological level), it will lead to a significant change in the amount of scattered light and the gradual loss of corneal transparency, this is known as corneal opacification which can be due to corneal edema or corneal scarring. Corneal opacity is one of the leading causes of reversible blindness and visual impairment. When corneal opacity progresses to the end-stage disease, the current and only option would be undergoing corneal transplantation. However, there is a global shortage of donor corneas furthermore, patients who undergo corneal transplantation would require life-long topical immunosuppressant. Hence, monitoring the progression of corneal edema or corneal scarring is essential to help prevent the disease from reaching the end stage. However, a direct marker for the evaluation of corneal edema remains lacking.

THz waves are electromagnetic radiation, and have emerged as a novel, non-invasive and non-contact imaging modality in the biomedical field, with a fast-scanning speed (30ms per scan) to meet medical diagnostic needs. With its fast scanning, it provides a more accurate result for the estimation of corneal thickness. Its high sensitivity hydration absorption and characterization peaks of collagen will provide a useful tool to obtain information that are related to the corneal layers. Water has a high dielectric constant and is highly absorptive to THz spectrum. This allows THz wave to be highly sensitive to water content in tissue. Furthermore, THz scan has been applied to a variety of hydration-related diseases or conditions. With THz scan, early detection of disease and diagnosis can be carried out. Some examples would be the prediction of skin flap failure, diagnosis for the presence of caries lesion at its initial stage, identification of skin cancer in skin biopsy samples and to access the physiological dynamics of tear film in dry eye syndrome. Previous studies have demonstrated that THz scanning system could be used as an early diagnostic tool, to identify the cancerous area based on the lack of clear cellular order in the skin. It was able to detect disease conditions in deeper layers, allowing it to be an effective early diagnostic tool for basal cell carcinoma. Moreover, it had been confirmed that THz scanning system had the sensitivity to identify the difference in colon tissue composition. The findings showed that the properties of ex vivo tissue, had an increase in both absorption coefficient and refractive indices in disease tissue when compared to healthy tissue. A recent study showed that with THz scanning system, clinicians will be able to obtain different images, such as 3D imaging methods to provide multiple views of internal structures. Furthermore, with the THz scan, the process of water loss in an in vitro porcine corneal tissue could be determined using a THz reflection imaging system. It was found that THz wave was approximately linear to the water content concentration, and that the slope decreased monotonously with an increase in frequency. These results suggest that THz imaging can be used for the clinical diagnosis of corneal edema or scars, dry eye diseases and corneal hydration in refractive surgery. With this, investigators would like to conduct this study to ascertain the safety of THz imaging system on humans.

Being tested
Terahertz (THz) scanning using THz Imaging system.
Keywords
cornea, corneal edema, Terahertz, hydration
Medical subject headings
Corneal Diseases, Corneal Edema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT06967792
Study groupRoleWhat they receive
Blind groupEyes that are deemed functionally blind but contain healthy corneas.
Receives: Device: Terahertz (THz) scanning using THz Imaging system.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 month

Secondary outcomes (10)
  1. 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.

    Measured: 1 month

  2. Extent of anterior chamber (AC) inflammation

    AC cells will be graded by the Standardization of Uveitis Nomenclature Working Group on the ordinal scale of 0(<1 cell/1 square millimeter, high-intensity beam), 0.5+ (1 to 5 cells/beam), 1+ (6 to 15 cells/beam), 2+ (16 to 25 cells/beam), 3+ (26 to 50 cells/beam), or 4+ (more than 50 cells/beam).

    Measured: 1 month

  3. Lens density grade

    Lens density will be also evaluated using the Pentacam device. Pentacam Nuclear Staging will provide a cataract grading score on an ordinal scale (from 0 to 5).

    Measured: 1 month

  4. Level of anterior chamber (AC) flare

    AC flare will be graded on the ordinal scale of 0 (none), 1+ (faint), 2+ (moderate; iris and lens details clear), 3+ (marked; iris and lens details hazy), or 4+ (fibrin or plastic aqueous).

    Measured: 1 month

  5. Level of conjunctival hyperemia

    The conjunctival hyperemia will be graded by the Food and Drug Administration (FDA) grading scale: 0 (None), 1 (Trace), 2 (Mild), 3 (Moderate), and 4 (Severe).

    Measured: 1 month

  6. Severity of lens opacity

    The lens opacity will be graded using the Lens Opacities Classification System III (LOCS III).

    Measured: 1 month

  7. 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.

    Measured: 1 month

  8. Corneal endothelium morphology profiles

    Specular Microscopy will be used to examine eight morphometric parameters of the corneal endothelium.

    Measured: 1 month

  9. 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.

    Measured: 1 month

  10. Fundus healthy status

    The fundus photographs will be taken 30 minutes after instillation of dilation eye drops (1% tropicamide (Alcon, USA) and a detailed evaluation of changes in fundus health will be made by an ophthalmologist.

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2025
  2. Study start1 Apr 2024
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion30 Apr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
5 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06967792
Sponsor's protocol ID
R2022-2604
Status last verified
May 2025
First submitted
4 May 2025
Last updated
16 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Corneal Diseases, run by Singapore Eye Research Institute at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yu-Chi Liu (65 65767287, liu.yu.chi@snec.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Level of visual acuity (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.

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