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

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.

Study Overview

• Status: Withdrawn
• Conditions: Eye Diseases
• Intervention / Treatment: Diagnostic test: Measurement of corneal biomechanical properties

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 Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Glaucoma; Patients with diagnosis of glaucoma, that are receiving or had surgery to treat glaucoma	Diagnostic test: Measurement of corneal biomechanical properties; Measurement of corneal biomechanics
Ocular hypertension; Patients with diagnosis of ocular hypertension, that are receiving or had surgery to treat ocular hypertension	Diagnostic test: Measurement of corneal biomechanical properties; Measurement of corneal biomechanics
Keratoconus; Patients with diagnosis of keratoconus, that are receiving or had surgery to treat keratoconus	Diagnostic test: Measurement of corneal biomechanical properties; Measurement of corneal biomechanics
Healthy controls; Healthy	Diagnostic test: Measurement of corneal biomechanical properties; Measurement of corneal biomechanics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First applanation velocity	Velocity during the first applanation of the cornea, measured using Corivs ST [m/s]	Day 1
First applanation time	Time frame of the first applanation of the cornea, measured using Corivs ST [s]	Day 1
First applanation lenght	Lenght of the first applanation of the cornea, measured using Corivs ST [mm]	Day 1
Second applanation velocity	Velocity during the second applanation of the cornea, measured using Corivs ST [m/s]	Day 1
Second applanation time	Time frame of the second applanation of the cornea, measured using Corivs ST [s]	Day 1
Second applanation lenght	Lenght of the second applanation of the cornea, measured using Corivs ST [mm]	Day 1
Highest concavity time	Time frame at highest concavity, measured using Corivs ST [s]	Day 1
Highest concavity peak distance	Distance between the 2 surrounding peaks at the highest concavity, measured using Corivs ST [mm]	Day 1
Highest concavity radius	Radius of curvature at highest concavity, measured using Corivs ST [mm]	Day 1
Highest concavity deformation amplitude	Maximal displacement of corneal apex between normal corneal shape and highest concavity, measured using Corivs ST [mm]	Day 1
Corneal hysteresis	Difference in terms of intensity of puff of air between the first and second applanation, measured using ORA [mmHg]	Day 1
Corneal resistance factor	Overall resistance of the cornea, measured using ORA [mmHg]	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraocular pressure measured using Corvis ST	Value of intraocular pressure measured according to the pressure of the air needed to applanate the cornea.	Day 1
Intraocular pressure measured using ORA	Value of intraocular pressure measured according to the pressure of the air needed to applanate the cornea.	Day 1
Pachymetry	Measure of corneal thickness using Corvis ST	Day 1

Collaborators and Investigators

• Sponsor: Aston University
• Collaborators: Sandwell & West Birmingham Hospitals NHS Trust
• Investigators: Principal Investigator: Shehzad A Naroo, PhD, Aston University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2022
• Primary Completion (Estimated): June 1, 2023
• Study Completion (Estimated): June 1, 2023

Study Registration Dates

• First Submitted: July 25, 2022
• First Submitted That Met QC Criteria: August 1, 2023
• First Posted (Actual): August 3, 2023

Study Record Updates

• Last Update Posted (Actual): August 3, 2023
• Last Update Submitted That Met QC Criteria: August 1, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Ocular Hypertension; Glaucoma; Keratoconus; Machine Learning; Corneal Biomechanics
• Additional Relevant MeSH Terms: Eye Diseases
• Other Study ID Numbers: 005-2021-SN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No