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

Insel Gruppe AG, University Hospital Bern

Status: Unknown

Conditions: Keratoconus; Cataract; Eye Diseases; Corneal Ectasia

Treatments: Other: retrospective analysis, no intervention; Device: Corneal tomography with Eyestar 900; Device: Biometry with IOL-Master; Device: Corneal tomography with Pentacam

Study type: Observational

Funder types: Other

Identifiers

NCT04763785

DKDA-E900-2020

Details and patient eligibility

About

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

Full description

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.

Enrollment: 4,800 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

4,800 participants in 3 patient groups

Patients with keratoconus corneas

Description:

Corneal tomography on patients with keratoconus diagnosis

Treatment:

Device: Corneal tomography with Pentacam

Device: Biometry with IOL-Master

Device: Corneal tomography with Eyestar 900

participants with healthy corneas

Description:

Corneal tomography on healthy participants

Treatment:

Device: Corneal tomography with Pentacam

Device: Biometry with IOL-Master

Device: Corneal tomography with Eyestar 900

retrospective part

Description:

fully anonymised Picture data of existing 4500 patients

Treatment:

Other: retrospective analysis, no intervention