Actively Recruiting
Validation of the Use of Terahertz Scanning System on Corneal Scars and Corneal Edema: Phase II Clinical Trial
Led by Singapore Eye Research Institute · Updated on 2025-05-21
150
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of a Terahertz (THz) scanning system as a new imaging method for people with corneal edema or corneal scars. These eye conditions can cause vision problems and may lead to corneal transplantation when advanced. The study aims to see if this THz scanning system can accurately measure the hydration level and density of the cornea, which current clinical tools cannot do objectively. This could help in early detection and better monitoring of disease progression to guide treatment decisions. The study involves patients with corneal endothelial dysfunction causing edema or those with corneal scars without edema. Participants will undergo a quick, non-invasive THz scan that takes about one second, developed by the Institute of Materials Research and Engineering in Singapore. This will be followed by standard clinical examinations to compare results. The THz system's performance will be assessed by correlating its measurements with traditional clinical methods. During the study, participants will have their eyes scanned with the THz device and undergo various clinical assessments such as corneal thickness, density, and appearance evaluations. Researchers will measure several baseline outcomes including the National Eye Institute (NEI) Score and keratocyte activation extent. This observational study is led by the Singapore Eye Research Institute and will run until August 2026. Participants will be monitored at scheduled visits to collect detailed data on their eye condition.
CONDITIONS
Brief Title
Validation of the Use of Terahertz Scanning System on Corneal Scars and Corneal Edema
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be at least 21 years of age.
- Any gender (male or female).
- Any race (Chinese, Malay, Indian, Eurasian, others).
- Willing and able to follow study instructions and schedule.
- Have corneal endothelial dysfunction (such as Fuchs' endothelial dystrophy or bullous keratopathy) at any stage, or have corneal scars without corneal edema.
- Able to hold face steady for eye scans.
You will not qualify if you...
- Eyes with active inflammation or infection, or chronic ocular surface inflammation.
- Unable to give consent.
- Physically immobile or unable to comply with instructions.
- As determined by the principal investigator.
- Pregnant or breastfeeding women.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 years
Participants undergo non-invasive THz scanning to measure corneal hydration status and evaluate corneal scars or edema using a prototype imaging system.
1 or more visits depending on cohort assignment
Trial Site Locations
Total: 1 location
1
Singapore National Eye Centre
Singapore, Singapore, S169856
Actively Recruiting
Research Team
Y
Yu-Chi Liu, MD, MCI, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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