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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with keratoconus corneas | Corneal tomography on patients with keratoconus diagnosis |
| |
| participants with healthy corneas | Corneal tomography on healthy participants |
| |
| retrospective part | fully anonymised Picture data of existing 4500 patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corneal tomography with Eyestar 900 | Device | Non-invasive corneal tomography to develop an imaging analysis algorithm for keratoconus corneas |
|
| Measure | Description | Time Frame |
|---|---|---|
| Keratoconus identification | Classification accuracy of the keratoconus identification algorithm for the Eyestar device in comparison to the gold standard (Belin-Ambrosio Enhanced Extasia Deviation Index) BAD_D in Pentacam images. | 2.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility in clinical practice | Evaluation of the feasibility (percentage of valid measurements without errors and/or problems in image aquisition) of cornea measurements in keratoconus and healthy eyes. | 2.5 years |
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Inclusion Criteria:
Exclusion Criteria:
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retrospective part: anonymised picture-data of 4500 patients prospective part: 150 keratoconus patients and 150 healthy participants
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| Name | Affiliation | Role |
|---|---|---|
| Früh Beatrice, Prof.Dr. med. | Universitätsklinik für Augenheilkunde, Inselspital Bern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinik für Augenheilkunde, Inselspital | Bern | 3010 | Switzerland |
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| Corneal tomography with Pentacam | Device | Non-invasive corneal tomography to develop an imaging analysis algorithm for keratoconus corneas |
|
| Biometry with IOL-Master | Device | Non-invasive biometry for presurgical intraocular lens calculation |
|
| retrospective analysis, no intervention | Other | retrospective analysis of 4500 existing, fully anonymised picture data |
|
| ID | Term |
|---|---|
| D007640 | Keratoconus |
| D005128 | Eye Diseases |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D007905 | Lens Diseases |
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| ID | Term |
|---|---|
| D001699 | Biometry |
| ID | Term |
|---|---|
| D013223 | Statistics as Topic |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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