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Development of a Keratoconus Detection Algorithm by Deep Learning Analysis and Its Validation on Eyestar Images

NCT ID: NCT04763785

Last Updated: 2021-09-30

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

UNKNOWN

Total Enrollment

4800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-11

Study Completion Date

2023-12-01

Brief Summary

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Monocentric clinical study to develop an imaging analysis algorithm for the Eyestar 900 to identify keratoconus corneas and improve biometry for intraocular lens calculations

Detailed Description

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Keratoconus is a progressive corneal ectatic disorder, characterised by thinning, protrusion and irregularity. Corneal imaging is crucial in keratoconus detection and progression analysis. Detection of keratoconus in early stages is important and has therapeutic consequence, whether to plan a surgical intervention or calculating an intraocular lens, before cataract surgery, as standard lens calculation techniques may lead to wrong results in patients with a keratoconus.

The Eyestar 900 is a swept-source OCT biometer and has the potential to be used for early keratoconus identification and progression analysis.

Conditions

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Keratoconus Eye Diseases Cataract Corneal Ectasia

Keywords

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Keratoconus Eye Diseases Cataract Corneal Imaging Corneal Topography Corneal Tomography Corneal Ectasia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with keratoconus corneas

Corneal tomography on patients with keratoconus diagnosis

Corneal tomography with Eyestar 900

Intervention Type DEVICE

Non-invasive corneal tomography to develop an imaging analysis algorithm for keratoconus corneas

Corneal tomography with Pentacam

Intervention Type DEVICE

Non-invasive corneal tomography to develop an imaging analysis algorithm for keratoconus corneas

Biometry with IOL-Master

Intervention Type DEVICE

Non-invasive biometry for presurgical intraocular lens calculation

participants with healthy corneas

Corneal tomography on healthy participants

Corneal tomography with Eyestar 900

Intervention Type DEVICE

Non-invasive corneal tomography to develop an imaging analysis algorithm for keratoconus corneas

Corneal tomography with Pentacam

Intervention Type DEVICE

Non-invasive corneal tomography to develop an imaging analysis algorithm for keratoconus corneas

Biometry with IOL-Master

Intervention Type DEVICE

Non-invasive biometry for presurgical intraocular lens calculation

retrospective part

fully anonymised Picture data of existing 4500 patients

retrospective analysis, no intervention

Intervention Type OTHER

retrospective analysis of 4500 existing, fully anonymised picture data

Interventions

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Corneal tomography with Eyestar 900

Non-invasive corneal tomography to develop an imaging analysis algorithm for keratoconus corneas

Intervention Type DEVICE

Corneal tomography with Pentacam

Non-invasive corneal tomography to develop an imaging analysis algorithm for keratoconus corneas

Intervention Type DEVICE

Biometry with IOL-Master

Non-invasive biometry for presurgical intraocular lens calculation

Intervention Type DEVICE

retrospective analysis, no intervention

retrospective analysis of 4500 existing, fully anonymised picture data

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Patients with all stages of keratoconus
2. Patients with healthy corneas

Exclusion Criteria

1. Keratoconus patients with hydrops, status following hydrops
2. Patients with degenerative corneal diseases
3. Patients after corneal surgery
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Früh Beatrice, Prof.Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinik für Augenheilkunde, Inselspital Bern

Locations

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Universitätsklinik für Augenheilkunde, Inselspital

Bern, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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DKDA-E900-2020

Identifier Type: -

Identifier Source: org_study_id