Development of an IT Tool Able to Identify Ocular Conditions

Withdrawn

• Conditions: Eye Diseases
• Interventions: Diagnostic Test: Measurement of corneal biomechanical properties

• Registration Number: NCT05973617
• Lead Sponsor: Aston University

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.

Study Timeline

• Study First Submitted: 2022-07-25
• Study Start: 2022-12
• Primary Completion: 2023-06
• Study Completion: 2023-06
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-01
• Last Update Submitted: 2023-08-01
• Study First Posted: 2023-08-03
• Last Update Posted: 2023-08-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Glaucoma	Measurement of corneal biomechanical properties	Patients with diagnosis of glaucoma, that are receiving or had surgery to treat glaucoma
Keratoconus	Measurement of corneal biomechanical properties	Patients with diagnosis of keratoconus, that are receiving or had surgery to treat keratoconus
Ocular hypertension	Measurement of corneal biomechanical properties	Patients with diagnosis of ocular hypertension, that are receiving or had surgery to treat ocular hypertension
Healthy controls	Measurement of corneal biomechanical properties	Healthy

Primary Outcome Measures

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

Secondary Outcome Measures

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