NCT05973617

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 3, 2023

Completed
Last Updated

August 3, 2023

Status Verified

August 1, 2023

Enrollment Period

6 months

First QC Date

July 25, 2022

Last Update Submit

August 1, 2023

Conditions

Eye Diseases

Keywords

Machine LearningGlaucomaKeratoconusOcular HypertensionCorneal Biomechanics

Outcome Measures

Primary Outcomes (12)

  • 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 Outcomes (3)

  • Intraocular pressure measured using Corvis ST

    Day 1

  • Intraocular pressure measured using ORA

    Day 1

  • Pachymetry

    Day 1

Study Arms (4)

Glaucoma

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

Diagnostic Test: Measurement of corneal biomechanical properties

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

Keratoconus

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

Diagnostic Test: Measurement of corneal biomechanical properties

Healthy controls

Healthy

Diagnostic Test: Measurement of corneal biomechanical properties

Interventions

Measurement of corneal biomechanical propertiesDIAGNOSTIC_TEST

Measurement of corneal biomechanics

GlaucomaHealthy controlsKeratoconusOcular hypertension

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Age below 18.
  • Participants who are not able to give informed consent.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Eye DiseasesGlaucomaKeratoconusOcular Hypertension

Condition Hierarchy (Ancestors)

Corneal Diseases

Study Officials

  • Shehzad A Naroo, PhD

    Aston University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2022

First Posted

August 3, 2023

Study Start

December 1, 2022

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

August 3, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share