Skip to content

Determination of corneal biomechanical properties in-vivo using a contact device

Determination of corneal biomechanical properties in-vivo using a contact device: a single-arm, observational study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN31552904
Enrollment
70
Registered
2014-07-23
Start date
2014-07-01
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Increased intraocular pressure of eye Eye Diseases

Interventions

The device applies indentation to the participant?s cornea and monitor the corneal deformation and load to measure the overall stiffness of the cornea. A computer is used to control the device and to

Sponsors

University of Liverpool (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. At least 18 years of age 2. Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant 3. Normal ophthalmic findings, other than high IOP 4. Astigmatism <2D 5. Potential to complete the study and comply with appropriate instructions 6. Signature on the informed consent form

Exclusion criteria

Exclusion criteria: 1. Corneal pathology or previous intra- or extra-ocular surgery, including refractive surgery (e.g., radial keratotomy, photorefractive keratotomy, LASIK, intracorneal ring), retinal surgery (e.g., buckle, photocoagulation), or implantation of a primary or secondary intraocular lens 2. Contact lens wearing within 3 days (rigid contact lenses) or 1 day (soft contact lenses) prior to study day 3. Inability to fully understand the ?informed consent? 4. Participants who are diabetic

Design outcomes

Primary

MeasureTime frame
Study B 1. The correlation between the force-displacement measurements made by the device and: 1.1. The overall stiffness as estimated mathematically based on the cornea?s thickness, topography and age 1.2.The differences in IOP readings made by two devices; namely the Goldmann Applanation Tonometer or GAT (which is known to be affected by corneal stiffness), and the Dynamic Contour Tonometer or DCT (which is known to be much less affected by corneal stiffness than GAT), 1.3. Corneal Resistance Factor, CRF (a stiffness-related parameter) as provided by the Ocular Response Analyzer (ORA). 1.4. The stiffness estimate provided by Corvis ST; a recently-released and not yet fully validated, non-contact device. 2. The correlation between the tissue hysteresis (difference in stress-strain behaviour under loading and unloading conditions) measured by the new device and the Corneal Hysteresis (CH) parameter provided by the Ocular Response Analyzer (ORA) 3. Estimation of tissue viscoelasticity

Secondary

MeasureTime frame
Study A 1. The reliability and repeatability of the device output 2. Comfort of use and tolerance of the new device 3. Assessment of general operation of device

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026