Biomechanical Properties of Keratoconic Eyes

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Keratoconus

Clinical Trial Details

NCT number	NCT02476149
Study type	Observational
Source	University of Plymouth
Contact	Phillip Buckhurst, PhD
Phone	01752 588884
Email	phillip.buckhurst@plymouth.ac.uk
Status	Recruiting
Phase
Start date	June 2015
Completion date	January 2020

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04570020` - Scleral Lens Fitting Using Wide-Field OCT
Recruiting	`NCT02921009` - McNeel Eye Center Corneal Crosslinking Study	N/A
Completed	`NCT01691651` - Botulinum Toxin A for the Treatment of Keratoconus	N/A
Terminated	`NCT02762253` - Study of the Safety and Effectiveness of Photochemically Induced Collagen Cross-Linking in Eyes With Keratoconus.	Phase 2
Completed	`NCT01527708` - Accuracy of Curvature and Wavefront Aberrations of Posterior Corneal Surface, in Keratoconic and Post-CXL Corneas	N/A
Completed	`NCT01527721` - Blurring Strength & Aberrometric Changes Following Corneal Cross-linking (CxL) and CxL Combined With Photorefractive Keratectomy (PRK) in Keratoconus	N/A
Recruiting	`NCT00841386` - Treatment of Keratoconus Using Collagen Cross-Linking	Phase 2/Phase 3
Completed	`NCT00347074` - A Clinical Study of Keratoconus in Asian Patients and Assessment of Different Topographic Patterns of Keratoconus in Asian Patients	N/A
Completed	`NCT03187912` - Accelerated Corneal Cross-linking With Different Riboflavin Solutions	Phase 3
Completed	`NCT00584285` - Corneal Topographer Fluorescein Patterns
Completed	`NCT03511495` - Reliability of Topography Measurements in Keratoconus
Not yet recruiting	`NCT05395650` - Cyanocobalamin as Photosensitizing Agent
Completed	`NCT04418999` - Safety and Efficacy of Intracanalicular Dexamethasone Compared to Loteprednol Etabonate in Patients With Keratoconus	Early Phase 1
Completed	`NCT03235856` - Retrospective Digital Computer Analysis of Keratoconus Evolution - REDCAKE
Completed	`NCT05019768` - Topo-pachimetric Accelerated Epi-On Cross-linking Compared to Dresden Protocol Using Riboflavin With Vitamin E TPGS	N/A
Withdrawn	`NCT01789333` - Higher Irradiance in Keratoconus Ectasia	N/A
Completed	`NCT05114928` - Correlation Between Q-value Changes and Progression of Pediatric Keratoconus.
Completed	`NCT03647046` - Custom Anterior Surfacing of Scleral Lens for Vision Quality Improvement in Patients With Keratoconus	N/A
Recruiting	`NCT04439552` - fMRI and IVCM Cornea Microscopy of CXL in Keratoconus
Recruiting	`NCT06100939` - Epithelium-On Corneal Cross-linking in Subjects 8 to 45 Years of Age With Keratoconus	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.