Eye DiseasesNCT05973617
Development of an IT Tool Able to Identify Ocular Conditions
An observational study of Eye Diseases, run by Aston University.
Trial summary
The aim of the study is to use machine learning to develop an IT tool able to differentiate between eye conditions analysing corneal biomechanical data. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Eye Diseases
- What is being tested?
- Measurement of corneal biomechanical properties
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2022to Jun 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult population. Study group: patients at Birmingham and Midlands Eye Centre. Control groups: healthy population recruited in Birmingham among staff and students at Aston University.
Who may be able to join
- Age above 18 years old.
- Participants who are able to give informed consent.
- Study groups: Patients with diagnosis of glaucoma or corneal disease or ocular hypertension. Patients that are having a treatment (medications or surgery) for glaucoma or ocular hypertension or corneal conditions.
- Control group: people with no diagnosis or treatment of previous pathologies.
Who cannot join
- Age below 18.
- Participants who are not able to give informed consent.
- Patients with eye conditions not within the inclusion criteria.
- Patients with respiratory distress or significant head tremor.
- Patients who are in pain or unable to remain seated for duration of measurements.
- Participants that during the visit are wearing contact lenses. The wear of contact lenses can alter the measure of corneal biomechanics.
About this study
Official title: A Prospective Observational Study to Investigate the Role of the Biomechanics of the Cornea in Identifying Glaucoma or Anterior Eye Diseases and Create an IT Tool Able to Distinguish Between Them
The aim of the study is to use machine learning to develop an IT tool able to differentiate between eye conditions analysing corneal biomechanical data.
Read the detailed description
Data will be collected using two different commercially available devices that are able to measure corneal biomechanics. Corneal biomechanics will be measured in participants with different conditions: glaucoma, ocular hypertension, corneal conditions, and healthy controls as it is well established that the above-mentioned conditions cause changes in corneal biomechanical properties.
Corneal biomechanics are the mechanical properties of the cornea, as rigidity, elasticity and it is possible to measure them using two devices: Ocular Response Analyzer (ORA) or Corneal Visualization Scheimpflug Technology (Corvis ST). Both devices use a puff of air to temporally flatten the cornea and derive the properties of the tissue.
Participants with ocular conditions will be recruited at Birmingham and Midlands Eye Centre (BMEC) at the Glaucoma and Anterior Eye clinics among patients attending for their routine clinical appointment. Healthy controls will be recruited at Aston University. This study requires only one visit and there is no need of follow up.
A portion of the data collected will be used to train machine learning algorithms to differentiate between conditions, the remaining data will be used to test the accuracy of newly created algorithms. The algorithm will be developed using Orange Data Mining.
- Conditions
- Eye Diseases
- Being tested
- Measurement of corneal biomechanical properties
- Keywords
- Machine Learning, Glaucoma, Keratoconus, Ocular Hypertension, Corneal Biomechanics
- Medical subject headings
- Eye Diseases, Glaucoma, Keratoconus, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of corneal biomechanical propertiesDiagnostic test
Measurement of corneal biomechanics
| Study group | Role | What they receive |
|---|---|---|
| Glaucoma | Patients with diagnosis of glaucoma, that are receiving or had surgery to treat glaucoma Receives: Diagnostic Test: Measurement of corneal biomechanical properties | |
| Ocular hypertension | Patients with diagnosis of ocular hypertension, that are receiving or had surgery to treat ocular hypertension Receives: Diagnostic Test: Measurement of corneal biomechanical properties | |
| Keratoconus | Patients with diagnosis of keratoconus, that are receiving or had surgery to treat keratoconus Receives: Diagnostic Test: Measurement of corneal biomechanical properties | |
| Healthy controls | Healthy Receives: Diagnostic Test: Measurement of corneal biomechanical properties |
What is being measured
The primary outcome is the main question the study is designed to answer.
First applanation velocity
Velocity during the first applanation of the cornea, measured using Corivs ST [m/s]
Measured: Day 1
First applanation time
Time frame of the first applanation of the cornea, measured using Corivs ST [s]
Measured: Day 1
First applanation lenght
Lenght of the first applanation of the cornea, measured using Corivs ST [mm]
Measured: Day 1
Second applanation velocity
Velocity during the second applanation of the cornea, measured using Corivs ST [m/s]
Measured: Day 1
Second applanation time
Time frame of the second applanation of the cornea, measured using Corivs ST [s]
Measured: Day 1
Second applanation lenght
Lenght of the second applanation of the cornea, measured using Corivs ST [mm]
Measured: Day 1
Highest concavity time
Time frame at highest concavity, measured using Corivs ST [s]
Measured: Day 1
Highest concavity peak distance
Distance between the 2 surrounding peaks at the highest concavity, measured using Corivs ST [mm]
Measured: Day 1
Highest concavity radius
Radius of curvature at highest concavity, measured using Corivs ST [mm]
Measured: Day 1
Highest concavity deformation amplitude
Maximal displacement of corneal apex between normal corneal shape and highest concavity, measured using Corivs ST [mm]
Measured: Day 1
Corneal hysteresis
Difference in terms of intensity of puff of air between the first and second applanation, measured using ORA [mmHg]
Measured: Day 1
Corneal resistance factor
Overall resistance of the cornea, measured using ORA [mmHg]
Measured: Day 1
Secondary outcomes (3)
Intraocular pressure measured using Corvis ST
Value of intraocular pressure measured according to the pressure of the air needed to applanate the cornea.
Measured: Day 1
Intraocular pressure measured using ORA
Value of intraocular pressure measured according to the pressure of the air needed to applanate the cornea.
Measured: Day 1
Pachymetry
Measure of corneal thickness using Corvis ST
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study startDec 2022 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Why it stopped: Study did not commence
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye DiseasesStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aston University
- Sponsor type
- University, hospital or other
- Collaborators
- Sandwell & West Birmingham Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Shehzad A Naroo, PhD, Principal investigator, Aston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05973617
- Sponsor's protocol ID
- 005-2021-SN
- Status last verified
- Aug 2023
- First submitted
- 25 Jul 2022
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study to Investigate the Role of the Biomechanics of the Cornea in Identifying Glaucoma or Anterior Eye Diseases and Create an IT Tool Able to Distinguish Between Them
- ClinicalTrials.gov ID
- NCT05973617
- Acronym / sponsor ID
- 005-2021-SN
- Conditions
- Eye Diseases
- Keywords
- Machine Learning, Glaucoma, Keratoconus, Ocular Hypertension, Corneal Biomechanics
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study did not commence
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Aston UniversityUniversity, hospital or other
- Collaborators
- Sandwell & West Birmingham Hospitals NHS Trust
- Study start
- Dec 2022 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 3 Aug 2023 (actual)
- 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.
The aim of the study is to use machine learning to develop an IT tool able to differentiate between eye conditions analysing corneal biomechanical data.
Detailed description
Data will be collected using two different commercially available devices that are able to measure corneal biomechanics. Corneal biomechanics will be measured in participants with different conditions: glaucoma, ocular hypertension, corneal conditions, and healthy controls as it is well established that the above-mentioned conditions cause changes in corneal biomechanical properties.
Corneal biomechanics are the mechanical properties of the cornea, as rigidity, elasticity and it is possible to measure them using two devices: Ocular Response Analyzer (ORA) or Corneal Visualization Scheimpflug Technology (Corvis ST). Both devices use a puff of air to temporally flatten the cornea and derive the properties of the tissue.
Participants with ocular conditions will be recruited at Birmingham and Midlands Eye Centre (BMEC) at the Glaucoma and Anterior Eye clinics among patients attending for their routine clinical appointment. Healthy controls will be recruited at Aston University. This study requires only one visit and there is no need of follow up.
A portion of the data collected will be used to train machine learning algorithms to differentiate between conditions, the remaining data will be used to test the accuracy of newly created algorithms. The algorithm will be developed using Orange Data Mining.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Glaucoma | – | Diagnostic Test: Measurement of corneal biomechanical propertiesPatients with diagnosis of glaucoma, that are receiving or had surgery to treat glaucoma |
| Ocular hypertension | – | Diagnostic Test: Measurement of corneal biomechanical propertiesPatients with diagnosis of ocular hypertension, that are receiving or had surgery to treat ocular hypertension |
| Keratoconus | – | Diagnostic Test: Measurement of corneal biomechanical propertiesPatients with diagnosis of keratoconus, that are receiving or had surgery to treat keratoconus |
| Healthy controls | – | Diagnostic Test: Measurement of corneal biomechanical propertiesHealthy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult population. Study group: patients at Birmingham and Midlands Eye Centre. Control groups: healthy population recruited in Birmingham among staff and students at Aston University.
Key inclusion criteria (4 listed)
- Age above 18 years old.
- Participants who are able to give informed consent.
- Study groups: Patients with diagnosis of glaucoma or corneal disease or ocular hypertension. Patients that are having a treatment (medications or surgery) for glaucoma or ocular hypertension or corneal conditions.
- Control group: people with no diagnosis or treatment of previous pathologies.
Key exclusion criteria (6 listed)
- Age below 18.
- Participants who are not able to give informed consent.
- Patients with eye conditions not within the inclusion criteria.
- Patients with respiratory distress or significant head tremor.
- Patients who are in pain or unable to remain seated for duration of measurements.
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 |
|---|---|---|
| Measurement of corneal biomechanical propertiesMeasurement of corneal biomechanics | Diagnostic test | Glaucoma, Healthy controls, Keratoconus, Ocular hypertension |
Primary outcome
First applanation velocity
Time frame: Day 1
Velocity during the first applanation of the cornea, measured using Corivs ST [m/s]
First applanation time
Time frame: Day 1
Time frame of the first applanation of the cornea, measured using Corivs ST [s]
First applanation lenght
Time frame: Day 1
Lenght of the first applanation of the cornea, measured using Corivs ST [mm]
Second applanation velocity
Time frame: Day 1
Velocity during the second applanation of the cornea, measured using Corivs ST [m/s]
Second applanation time
Time frame: Day 1
Time frame of the second applanation of the cornea, measured using Corivs ST [s]
Second applanation lenght
Time frame: Day 1
Lenght of the second applanation of the cornea, measured using Corivs ST [mm]
Highest concavity time
Time frame: Day 1
Time frame at highest concavity, measured using Corivs ST [s]
Highest concavity peak distance
Time frame: Day 1
Distance between the 2 surrounding peaks at the highest concavity, measured using Corivs ST [mm]
Highest concavity radius
Time frame: Day 1
Radius of curvature at highest concavity, measured using Corivs ST [mm]
Highest concavity deformation amplitude
Time frame: Day 1
Maximal displacement of corneal apex between normal corneal shape and highest concavity, measured using Corivs ST [mm]
Corneal hysteresis
Time frame: Day 1
Difference in terms of intensity of puff of air between the first and second applanation, measured using ORA [mmHg]
Corneal resistance factor
Time frame: Day 1
Overall resistance of the cornea, measured using ORA [mmHg]
3 secondary outcomes
Intraocular pressure measured using Corvis ST
Time frame: Day 1
Intraocular pressure measured using ORA
Time frame: Day 1
Pachymetry
Time frame: Day 1
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Individual participant dataSharing planned: No
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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.
Shehzad A Naroo, PhD principal investigator
Aston University
Questions about this trial
What is this clinical trial studying?
An observational study of Eye Diseases, run by Aston University.
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 4 inclusion and 6 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: withdrawn, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First applanation velocity (time frame: Day 1). The study lists 12 primary outcomes in all. 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 3 Aug 2023.