Evaluating the safety of Terahertz scanning on corneas
Evaluation of the Safety of Terahertz Scanning System on Corneas: Phase I Trial
This study is testing if a new Terahertz scanning system is safe to use on the corneas of people who can't see but have healthy eyes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Singapore Eye Research Institute Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Singapore, Singapore) |
| Trial ID | NCT06967792 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the safety of the Terahertz (THz) scanning system in individuals with non-seeing eyes but healthy corneas. Participants will undergo THz scanning, followed by comprehensive eye examinations at various intervals to monitor visual acuity, corneal health, and nerve status. The study hypothesizes that the THz scanning system is safe for application on the human cornea, which is crucial for understanding corneal hydration and preventing conditions like corneal opacification. The findings could provide insights into non-invasive monitoring techniques for corneal diseases.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 21 and older with at least one functionally blind eye that has a healthy cornea.
Not a fit: Patients with a history of major corneal surgery, active inflammation, or systemic diseases affecting the ocular surface may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer and more effective monitoring of corneal diseases, potentially preventing irreversible blindness.
How similar studies have performed: While the use of Terahertz imaging is a novel approach in this context, similar imaging techniques have shown promise in other areas of ocular health.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Singapore, Singapore
- Singapore National Eye Centre — Singapore, Singapore, Singapore (Recruiting)
Study contacts
- Study coordinator: Yu-Chi Liu
- Email: liu.yu.chi@snec.com.sg
- Phone: 65 65767287
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.