KeratoconusNCT02476149
Biomechanical Properties of Keratoconic Eyes
An observational study of Keratoconus, run by University of Plymouth at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratoconus
- What is being tested?
- Corneal Cross-linking
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2015to Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Potential participants will be identified as those patients who are due to undergo corneal collagen crosslinking treatment
Who may be able to join
- Adult subjects over the age of 18 with keratoconus who are enrolled for collagen crosslinking treatment
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Plymouth University
Plymouth, Devon, PL6 8BH
Hetal Buckhurst, 01752 588886, hetal.buckhurst@plymouth.ac.uk
About this study
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.
- Conditions
- Keratoconus
- Being tested
- Corneal Cross-linking
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corneal Cross-linkingProcedure or surgery
All participants recruited for the study will be scheduled for corneal crosslinking treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the corneal hysteresis following corneal crosslinking (mmHg)
Corneal hysteresis as measured using the CorvisST
Measured: Up to 3 months prior to corneal collagen crosslinking treatment and at 3-6 months after treatment
Secondary outcomes (6)
Change of refractive error following corneal crosslinking (LogMAR)
Refractive error measured using objective refraction
Measured: Up to 3 months prior to corneal collagen crosslinking treatment and at 3-6 months after treatment
Axial Length prior to corneal crosslinking (mm)
Axial length determined with the LenStar
Measured: Up to 3 months prior to corneal collagen crosslinking treatment
Axial Length axial length following corneal crosslinking (mm)
Axial length determined with the LenStar
Measured: At 3-6 months after treatment
Change in corneal curvature following corneal crosslinking (mm)
Corneal curvature assessed with the Pentacam HR
Measured: Up to 3 months prior to corneal collagen crosslinking treatment and at 3-6 months after treatment
Tear break up time prior to corneal crosslinking (s)
Tear break up time determined using the Oculus K5
Measured: Up to 3 months prior to corneal collagen crosslinking treatment
Tear break up time following corneal crosslinking (s)
Tear break up time determined using the Oculus K5
Measured: At 3-6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratoconusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Plymouth
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Phillip J Buckhurst, University of Plymouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02476149
- Sponsor's protocol ID
- 15/SW/0107
- Status last verified
- Jan 2019
- First submitted
- 14 Jun 2015
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomechanical Properties of Keratoconic Eyes
- ClinicalTrials.gov ID
- NCT02476149
- Acronym / sponsor ID
- 15/SW/0107
- Conditions
- Keratoconus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University of PlymouthUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 19 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Potential participants will be identified as those patients who are due to undergo corneal collagen crosslinking treatment
Key inclusion criteria (1 listed)
- Adult subjects over the age of 18 with keratoconus who are enrolled for collagen crosslinking treatment
Key exclusion criteria (4 listed)
- Any patient who has had surgical complications will also be excluded from participation in the study.
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corneal Cross-linkingAll participants recruited for the study will be scheduled for corneal crosslinking treatment | Procedure or surgery | – |
Primary outcome
Change of the corneal hysteresis following corneal crosslinking (mmHg)
Time frame: Up to 3 months prior to corneal collagen crosslinking treatment and at 3-6 months after treatment
Corneal hysteresis as measured using the CorvisST
6 secondary outcomes
Change of refractive error following corneal crosslinking (LogMAR)
Time frame: Up to 3 months prior to corneal collagen crosslinking treatment and at 3-6 months after treatment
Axial Length prior to corneal crosslinking (mm)
Time frame: Up to 3 months prior to corneal collagen crosslinking treatment
Axial Length axial length following corneal crosslinking (mm)
Time frame: At 3-6 months after treatment
Change in corneal curvature following corneal crosslinking (mm)
Time frame: Up to 3 months prior to corneal collagen crosslinking treatment and at 3-6 months after treatment
Tear break up time prior to corneal crosslinking (s)
Time frame: Up to 3 months prior to corneal collagen crosslinking treatment
Tear break up time following corneal crosslinking (s)
Time frame: At 3-6 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Keratoconus, run by University of Plymouth at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Phillip Buckhurst, PhD (01752 588884, phillip.buckhurst@plymouth.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the corneal hysteresis following corneal crosslinking (mmHg) (time frame: Up to 3 months prior to corneal collagen crosslinking treatment and at 3-6 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2019.