Clinical trial NCT05973617: Development of an IT Tool Able to Identify Ocular Conditions
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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Eye Diseases
Keywords: Machine Learning
Glaucoma
Keratoconus
Ocular Hypertension
Corneal Biomechanics
Lead sponsor: Aston University
Sponsor class: OTHER
Collaborators: name: Sandwell & West Birmingham Hospitals NHS Trust
First posted: 2023-08-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: First applanation velocity
timeFrame: Day 1
measure: First applanation time
timeFrame: Day 1
measure: First applanation lenght
timeFrame: Day 1
measure: Second applanation velocity
timeFrame: Day 1
measure: Second applanation time
timeFrame: Day 1
measure: Second applanation lenght
timeFrame: Day 1
measure: Highest concavity time
timeFrame: Day 1
measure: Highest concavity peak distance
timeFrame: Day 1
measure: Highest concavity radius
timeFrame: Day 1
measure: Highest concavity deformation amplitude
timeFrame: Day 1
measure: Corneal hysteresis
timeFrame: Day 1
measure: Corneal resistance factor
timeFrame: Day 1
Secondary outcomes:
measure: Intraocular pressure measured using Corvis ST
timeFrame: Day 1
measure: Intraocular pressure measured using ORA
timeFrame: Day 1
measure: Pachymetry
timeFrame: Day 1
Other outcomes:
Locations:
Study officials:
affiliation: Aston University
name: Shehzad A Naroo, PhD
role: PRINCIPAL_INVESTIGATOR
References: