Occyo Tele-ophthalmology Study

NCT ID: NCT06681350

Last Updated: 2024-11-21

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

RECRUITING

Clinical Phase

NA

Total Enrollment

365 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-15

Study Completion Date

2026-10-31

Brief Summary

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The prospective, (observer) blinded clinical trial at the University Hospital for Ophthalmology includes patients routinely scheduled for cataract surgery at the Medical University of Innsbruck.

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.

Detailed Description

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Conditions

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Cataract

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Occyo One Anterior Segment Imaging

Imaging of the anterior segment of the eye for telemedical assessment.

Group Type OTHER

Ocular surface imaging

Intervention Type DEVICE

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Understands and agrees to comply with the study procedures and provides written informed consent as documented by signature
2. Patients scheduled to undergo cataract surgery
3. Male or female patient aged ≥ 50 years at time of consent

Exclusion Criteria

1\. Woman of childbearing potential (WOCBP)
Minimum Eligible Age

50 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University Innsbruck

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Medical University Innsbruck, University Hospital for Ophthalmology and Optometry

Innsbruck, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Christoph Palme, Dr.

Role: CONTACT

+43 (0)512 504-23720

Facility Contacts

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Christoph Palme, Dr.

Role: primary

+43 (0)512/504-23720

Other Identifiers

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OTS

Identifier Type: -

Identifier Source: org_study_id

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