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This multi-centric, prospective observational study collects biometric datasets as well as associated video recordings of the surgical procedure.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optical Biometry | Device | Biometric measurements of the eye used for surgical planning will be obtained. | ||
| Cataract Surgery | Procedure | A video recording of the surgical procedure will be obtained. |
| Measure | Description | Time Frame |
|---|---|---|
| Biometric data | collect anonymised biometric data from patients undergoing elective cataract surgery | one-time measurement before surgery |
| Video recording | collect anonymised video recording of surgical procedure from patients undergoing elective cataract surgery | during the surgical procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Software algorith | Verification of software algorithms that use the biometric data to analyse the video recordings. | up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Any individual over the age of 21 seeking elective cataract surgery at the study sites.
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| Name | Affiliation | Role |
|---|---|---|
| Jan Rübel, PhD | Haag-Streit | Study Chair |
| Julian V Kool van Langenberghe, ing | Haag-Streit | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East Valley Ophthalmology | Mesa | Arizona | 85206 | United States | ||
| Pacific Clear Vision Institute |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 18, 2025 | Jun 3, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D002387 | Cataract Extraction |
| ID | Term |
|---|---|
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Eugene |
| Oregon |
| 97401 |
| United States |