Health TrialsbyHealthPanel

Evaluation of the Safety of Terahertz Scanning System on Corneas

ConditionCorneal Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21+
SponsorSingapore Eye Research Institute

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

5 Participants
are divided into 1 treatment group
Group A: Blind group1 intervention

Trial outcomes

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.

Time frame
1 month

Secondary outcomes

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.

Time frame
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).

Time frame
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).

Time frame
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).

Time frame
1 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Singapore Eye Research Institute

Lead sponsor

Source ClinicalTrials.gov
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