Study Results
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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RECRUITING
NA
365 participants
INTERVENTIONAL
2024-10-15
2026-10-31
Brief Summary
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Patients are enrolled one week prior to their planned cataract surgery. The participants will undergo a screening in which, in addition to the ophthalmological standard examinations, Occyo One images of the anterior segment of the eye are taken. After surgery, a post-operative follow-up visit takes place and a second set of Occyo One images will be generated.
During the postoperative check-up, the study team at the trial center decides-based on defined criteria (medical history, slit lamp examination results)-whether a change in the subsequent patient management is necessary due to the presence of postoperative complications (unexpected management changes = UMC).
Up on completion of all patient visits/study-specific measurements and data collection, information regarding diagnostic criteria and the Occyo One images are sent to an external, blinded ophthalmologist for telemedical assessment. Based on the available information and images, the blinded ophthalmologist decides whether a change in patient management should have been made or not.
The difference in the detection of an event resulting in a UMC is the primary objective of this clinical investigation.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Occyo One Anterior Segment Imaging
Imaging of the anterior segment of the eye for telemedical assessment.
Ocular surface imaging
Telemedical examination of high-resolution, all-in-focus images of the cornea, sclera, conjunctiva, and lid margins for montioring of postoperative complications
Interventions
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Ocular surface imaging
Telemedical examination of high-resolution, all-in-focus images of the cornea, sclera, conjunctiva, and lid margins for montioring of postoperative complications
Eligibility Criteria
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Inclusion Criteria
2. Patients scheduled to undergo cataract surgery
3. Male or female patient aged ≥ 50 years at time of consent
Exclusion Criteria
50 Years
99 Years
ALL
No
Sponsors
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Medical University Innsbruck
OTHER
Responsible Party
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Locations
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Medical University Innsbruck, University Hospital for Ophthalmology and Optometry
Innsbruck, , Austria
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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OTS
Identifier Type: -
Identifier Source: org_study_id
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