Corneal DiseasesNCT06983652
Validation of the Use of Terahertz Scanning System on Corneal Scars and Corneal Edema
An observational study of Corneal Diseases and Corneal Scars and Opacities, run by Singapore Eye Research Institute at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Corneal Diseases, Corneal Scars and Opacities, Corneal Edema
- What is being tested?
- THz scanning using THz Imaging system.
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Jul 2024to 31 Aug 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 150 participants with corneal diseases, including corneal scars and corneal edema, 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.
- 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.
Who cannot join
- 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
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
- Recruiting
Singapore National Eye Centre
Singapore, S169856
Yu-Chi Liu, MD, MCI, PhD, 65 65767287, liu.yu.chi@snec.com.sg
About this study
Official title: Validation of the Use of Terahertz Scanning System on Corneal Scars and Corneal Edema: Phase II Clinical Trial
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.
Read the detailed description
Corneal opacity is one of the main causes of low vision and visual impairment, which results from two pathological etiologies: corneal edema and corneal scarring. When corneal opacity progresses to end-stage disease, the only option is to undergo a corneal transplantation. There is a global shortage of donor corneas and patients who undergo corneal transplantation require life-long topical immunosuppressant treatment, hence monitoring the progression of corneal edema or corneal scarring to prevent the disease entering into the end stage is crucial. Monitoring the progression of diseases also allows surgeons to do earlier intervention with less invasive techniques, such as lamellar corneal graft, as opposed to full-thickness graft. Currently there is no objective tool clinically to quantitatively evaluate corneal opacity and there is no tool to directly evaluate corneal hydration level. Hence, there is a need to develop a quantitative tool to evaluate the density of corneal opacities. There is a need to develop a medical tool to evaluate the corneal scar objectively and quantitatively, to better monitor the disease progression and aid in the surgical decision making.
Terahertz (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. Thus THz imaging is suggested to be used for the clinical diagnosis of corneal edema or scars, dry eye diseases and corneal hydration in refractive surgery.
The investigators would like to conduct the clinical trial to validate the use of THz scanning system in human corneal edema and corneal scars.
- Conditions
- Corneal Diseases, Corneal Scars and Opacities, Corneal Edema
- Being tested
- THz scanning using THz Imaging system.
- Keywords
- cornea, corneal scar, corneal edema, Terahertz, hydration
- Medical subject headings
- Corneal Diseases, Corneal Injuries, Corneal Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: THz scanning using THz Imaging system. | |
| Corneal scar cohort | Patients with corneal scars from any cause, with the absence of corneal edema. Receives: Device: THz scanning using THz Imaging system. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start1 Jul 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore Eye Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06983652
- Sponsor's protocol ID
- 2024-3286
- Status last verified
- May 2025
- First submitted
- 6 May 2025
- Last updated
- 21 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Use of Terahertz Scanning System on Corneal Scars and Corneal Edema: Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT06983652
- Acronym / sponsor ID
- 2024-3286
- Conditions
- Corneal Diseases, Corneal Scars and Opacities, Corneal Edema
- Keywords
- cornea, corneal scar, corneal edema, Terahertz, hydration
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Singapore Eye Research InstituteUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Corneal opacity is one of the main causes of low vision and visual impairment, which results from two pathological etiologies: corneal edema and corneal scarring. When corneal opacity progresses to end-stage disease, the only option is to undergo a corneal transplantation. There is a global shortage of donor corneas and patients who undergo corneal transplantation require life-long topical immunosuppressant treatment, hence monitoring the progression of corneal edema or corneal scarring to prevent the disease entering into the end stage is crucial. Monitoring the progression of diseases also allows surgeons to do earlier intervention with less invasive techniques, such as lamellar corneal graft, as opposed to full-thickness graft. Currently there is no objective tool clinically to quantitatively evaluate corneal opacity and there is no tool to directly evaluate corneal hydration level. Hence, there is a need to develop a quantitative tool to evaluate the density of corneal opacities. There is a need to develop a medical tool to evaluate the corneal scar objectively and quantitatively, to better monitor the disease progression and aid in the surgical decision making.
Terahertz (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. Thus THz imaging is suggested to be used for the clinical diagnosis of corneal edema or scars, dry eye diseases and corneal hydration in refractive surgery.
The investigators would like to conduct the clinical trial to validate the use of THz scanning system in human corneal edema and corneal scars.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corneal edema cohort | – | Device: THz scanning using THz Imaging system.Patients with corneal endothelial dysfunction (Fuchs' endothelial dystrophy or other causes of bullous keratopathy) at any disease stage, with manifestation of corneal edema. |
| Corneal scar cohort | – | Device: THz scanning using THz Imaging system.Patients with corneal scars from any cause, with the absence of corneal edema. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 150 participants with corneal diseases, including corneal scars and corneal edema, will be recruited from Singapore National Eye Centre.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THz 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. | Device | Corneal edema cohort, Corneal scar cohort |
Primary outcome
National Eye Institute (NEI) Score
Time frame: Baseline
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.
Central corneal thickness
Time frame: Baseline
Central corneal thickness (CCT) will be assessed using Anterior Segment Optical Coherence Tomography. The CCT will be measured using a build-in caliper software.
Measurements of corneal scars
Time frame: Baseline
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.
Level of corneal density
Time frame: Baseline
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.
Extent of keratocytes activation
Time frame: Baseline
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.
Overall appearance of corneas
Time frame: Baseline
External eye photos will be captured to record the status of corneas, showing the location and extent of involvement of the corneal lesion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Corneal Diseases and Corneal Scars and Opacities, 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 6 inclusion and 5 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 21 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, MD, MCI, PhD (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?
National Eye Institute (NEI) Score (time frame: Baseline). The study lists 6 primary outcomes in all. 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 21 May 2025.