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Biomechanical Properties of Keratoconic Eyes

Biomechanical Properties of Keratoconic Eyes

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02476149
Enrollment
35
Registered
2015-06-19
Start date
2015-06-30
Completion date
2020-01-31
Last updated
2019-01-23

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

Conditions

Keratoconus

Brief summary

In keratoconus (KC) corneal thinning and protrusion can cause myopia and irregular astigmatism, affecting vision. The biomechanical properties of the cornea is maintained by an intricate collagen network, which is responsible for its shape and function. In KC this collagen network is disrupted resulting in the cornea losing its shape and function. Keratoconic changes are focal and localised to certain regions of the cornea and the early detection of these changes is challenging. Screening methods include corneal topography (evaluation of anterior corneal surface curvature), tomography (assessing the morphological features of the anterior segment) and aberrometry (measuring the optical aberrations of the eye). More recent research suggests that the biomechanical destabilization of the cornea may precede topographic and tomographic evidence of KC. Management of KC depends on disease severity with severe cases being treated with keratoplasty and less severe cases with cornealcollagencrosslinking (CXL). CXL is an emerging technique, which aims to increase the biomechanical strength of the keratoconic cornea. Despite strong evidence of changes in the biomechanical properties in human corneas following CXL, there is a significant need for accurate measures of biomechanical changes in vivo pre and post CXL. Until recently technical limitations have restricted the ability to assess the biomechanical properties of the whole cornea in vivo. With the introduction of the CorvisST (Oculus) it is now possible to assess regional biomechanical behaviour of the cornea. The output from the device provides a variety of parameters to indicate the cornea's biomechanical strength. To date, the association between the deflection behaviours in various regions of the cornea in keratoconic eyes preand post CXL has not been studied. In order to effectively assess the clinical benefits of CXL such information is vital. The primary goal of this investigation is to investigate regional biomechanical properties of the keratoconic eye before and after CXL.

Interventions

All participants recruited for the study will be scheduled for corneal crosslinking treatment

Sponsors

University of Plymouth
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult subjects over the age of 18 with keratoconus who are enrolled for collagen crosslinking treatment

Exclusion criteria

* Any patient who has had surgical complications will also be excluded from participation in the study. Determination during enrolment: * Pregnancy or breastfeeding during the study * Any kind of systemic disease which affect collagen and the body water regulation system (Marfan syndrome, osteogenesis imperfect, pseudozanthoma elasticum, EhlersDanlos, diabetes, rosacea, acne, cardiovascular disease, thyroid disease)

Design outcomes

Primary

MeasureTime frameDescription
Change of the corneal hysteresis following corneal crosslinking (mmHg)Up to 3 months prior to corneal collagen crosslinking treatment and at 3-6 months after treatmentCorneal hysteresis as measured using the CorvisST

Secondary

MeasureTime frameDescription
Axial Length prior to corneal crosslinking (mm)Up to 3 months prior to corneal collagen crosslinking treatmentAxial length determined with the LenStar
Axial Length axial length following corneal crosslinking (mm)At 3-6 months after treatmentAxial length determined with the LenStar
Change of refractive error following corneal crosslinking (LogMAR)Up to 3 months prior to corneal collagen crosslinking treatment and at 3-6 months after treatmentRefractive error measured using objective refraction
Tear break up time prior to corneal crosslinking (s)Up to 3 months prior to corneal collagen crosslinking treatmentTear break up time determined using the Oculus K5
Tear break up time following corneal crosslinking (s)At 3-6 months after treatmentTear break up time determined using the Oculus K5
Change in corneal curvature following corneal crosslinking (mm)Up to 3 months prior to corneal collagen crosslinking treatment and at 3-6 months after treatmentCorneal curvature assessed with the Pentacam HR

Countries

United Kingdom

Contacts

Primary ContactPhillip Buckhurst, PhD
phillip.buckhurst@plymouth.ac.uk01752 588884
Backup ContactDaniela Oehring, MSc
daniela.oehring@plymouth.ac.uk+44 (0) 7584 428 035

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026