Biomechanical Properties of Keratoconic Eyes

• Conditions: Keratoconus

• Registration Number: NCT02476149
• Lead Sponsor: University of Plymouth

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-14
• Study First Submitted QC: 2015-06-18
• Study First Posted: 2015-06-19
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-22
• Last Update Posted: 2019-01-23
• Primary Completion: 2019-12
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 treatment	Corneal hysteresis as measured using the CorvisST

Secondary Outcome Measures

Name	Time	Method
Tear break up time prior to corneal crosslinking (s)	Up to 3 months prior to corneal collagen crosslinking treatment	Tear break up time determined using the Oculus K5
Axial Length prior to corneal crosslinking (mm)	Up to 3 months prior to corneal collagen crosslinking treatment	Axial length determined with the LenStar
Tear break up time following corneal crosslinking (s)	At 3-6 months after treatment	Tear break up time determined using the Oculus K5
Axial Length axial length following corneal crosslinking (mm)	At 3-6 months after treatment	Axial 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 treatment	Refractive error measured using objective refraction
Change in corneal curvature following corneal crosslinking (mm)	Up to 3 months prior to corneal collagen crosslinking treatment and at 3-6 months after treatment	Corneal curvature assessed with the Pentacam HR

Trial Locations

Locations (1)

Plymouth University; 🇬🇧 Plymouth, Devon, United Kingdom