Development of an IT Tool Able to Identify Ocular Conditions

NCT ID: NCT05973617

Last Updated: 2023-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-31

Study Completion Date

2023-06-30

Brief Summary

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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

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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

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Eye Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Glaucoma

Patients with diagnosis of glaucoma, that are receiving or had surgery to treat glaucoma

Measurement of corneal biomechanical properties

Intervention Type DIAGNOSTIC_TEST

Measurement of corneal biomechanics

Ocular hypertension

Patients with diagnosis of ocular hypertension, that are receiving or had surgery to treat ocular hypertension

Measurement of corneal biomechanical properties

Intervention Type DIAGNOSTIC_TEST

Measurement of corneal biomechanics

Keratoconus

Patients with diagnosis of keratoconus, that are receiving or had surgery to treat keratoconus

Measurement of corneal biomechanical properties

Intervention Type DIAGNOSTIC_TEST

Measurement of corneal biomechanics

Healthy controls

Healthy

Measurement of corneal biomechanical properties

Intervention Type DIAGNOSTIC_TEST

Measurement of corneal biomechanics

Interventions

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Measurement of corneal biomechanical properties

Measurement of corneal biomechanics

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

* 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.

Exclusion Criteria

* Age below 18.
* Participants who are not able to give informed consent.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sandwell & West Birmingham Hospitals NHS Trust

OTHER

Sponsor Role collaborator

Aston University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shehzad A Naroo, PhD

Role: PRINCIPAL_INVESTIGATOR

Aston University

Other Identifiers

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005-2021-SN

Identifier Type: -

Identifier Source: org_study_id

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