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Development of an IT Tool Able to Identify Ocular Conditions

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05973617
Enrollment
0
Registered
2023-08-03
Start date
2022-12-31
Completion date
2023-06-30
Last updated
2023-08-03

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

Conditions

Eye Diseases

Keywords

Machine Learning, Glaucoma, Keratoconus, Ocular Hypertension, Corneal Biomechanics

Brief 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.

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.

Interventions

DIAGNOSTIC_TESTMeasurement of corneal biomechanical properties

Measurement of corneal biomechanics

Sponsors

Sandwell & West Birmingham Hospitals NHS Trust
CollaboratorOTHER
Aston University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

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

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Corneal resistance factorDay 1Overall resistance of the cornea, measured using ORA \[mmHg\]
Highest concavity radiusDay 1Radius of curvature at highest concavity, measured using Corivs ST \[mm\]
Highest concavity deformation amplitudeDay 1Maximal displacement of corneal apex between normal corneal shape and highest concavity, measured using Corivs ST \[mm\]
Corneal hysteresisDay 1Difference in terms of intensity of puff of air between the first and second applanation, measured using ORA \[mmHg\]
Highest concavity timeDay 1Time frame at highest concavity, measured using Corivs ST \[s\]
Second applanation lenghtDay 1Lenght of the second applanation of the cornea, measured using Corivs ST \[mm\]
First applanation lenghtDay 1Lenght of the first applanation of the cornea, measured using Corivs ST \[mm\]
Second applanation velocityDay 1Velocity during the second applanation of the cornea, measured using Corivs ST \[m/s\]
Second applanation timeDay 1Time frame of the second applanation of the cornea, measured using Corivs ST \[s\]
First applanation velocityDay 1Velocity during the first applanation of the cornea, measured using Corivs ST \[m/s\]
First applanation timeDay 1Time frame of the first applanation of the cornea, measured using Corivs ST \[s\]
Highest concavity peak distanceDay 1Distance between the 2 surrounding peaks at the highest concavity, measured using Corivs ST \[mm\]

Secondary

MeasureTime frameDescription
Intraocular pressure measured using ORADay 1Value of intraocular pressure measured according to the pressure of the air needed to applanate the cornea.
PachymetryDay 1Measure of corneal thickness using Corvis ST
Intraocular pressure measured using Corvis STDay 1Value of intraocular pressure measured according to the pressure of the air needed to applanate the cornea.

Outcome results

None listed

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