Development of an IT Tool Able to Identify Ocular Conditions

Eye Diseases Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05973617
• Other study ID #: 005-2021-SN
• Status: Withdrawn
• Start date: December 2022
• Est. completion date: June 2023

Study information

• Verified date: August 2023
• Source: Aston University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Eye Diseases

Intervention

Diagnostic Test:
• Measurement of corneal biomechanical properties
Measurement of corneal biomechanics

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Aston University	Sandwell & West Birmingham Hospitals NHS Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First applanation velocity	Velocity during the first applanation of the cornea, measured using Corivs ST [m/s]	Day 1
Primary	First applanation time	Time frame of the first applanation of the cornea, measured using Corivs ST [s]	Day 1
Primary	First applanation lenght	Lenght of the first applanation of the cornea, measured using Corivs ST [mm]	Day 1
Primary	Second applanation velocity	Velocity during the second applanation of the cornea, measured using Corivs ST [m/s]	Day 1
Primary	Second applanation time	Time frame of the second applanation of the cornea, measured using Corivs ST [s]	Day 1
Primary	Second applanation lenght	Lenght of the second applanation of the cornea, measured using Corivs ST [mm]	Day 1
Primary	Highest concavity time	Time frame at highest concavity, measured using Corivs ST [s]	Day 1
Primary	Highest concavity peak distance	Distance between the 2 surrounding peaks at the highest concavity, measured using Corivs ST [mm]	Day 1
Primary	Highest concavity radius	Radius of curvature at highest concavity, measured using Corivs ST [mm]	Day 1
Primary	Highest concavity deformation amplitude	Maximal displacement of corneal apex between normal corneal shape and highest concavity, measured using Corivs ST [mm]	Day 1
Primary	Corneal hysteresis	Difference in terms of intensity of puff of air between the first and second applanation, measured using ORA [mmHg]	Day 1
Primary	Corneal resistance factor	Overall resistance of the cornea, measured using ORA [mmHg]	Day 1
Secondary	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
Secondary	Intraocular pressure measured using ORA	Value of intraocular pressure measured according to the pressure of the air needed to applanate the cornea.	Day 1
Secondary	Pachymetry	Measure of corneal thickness using Corvis ST	Day 1