Actively Recruiting

Phase Not Applicable
Age: 50Years - 99Years
All Genders
NCT06681350

Occyo Tele-ophthalmology Study

Led by Medical University Innsbruck · Updated on 2024-11-21

365

Participants Needed

1

Research Sites

102 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Occyo Tele-ophthalmology Study

Who Can Participate

Age: 50Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Understands and agrees to comply with the study procedures and provides written informed consent as documented by signature
  • Patients scheduled to undergo cataract surgery
  • Male or female patient aged 6 50 years at time of consent
Not Eligible

You will not qualify if you...

  • Woman of childbearing potential (WOCBP)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Medical University Innsbruck, University Hospital for Ophthalmology and Optometry

Innsbruck, Austria, 6020

Actively Recruiting

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Research Team

C

Christoph Palme, Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

1

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Occyo Tele-ophthalmology Study | DecenTrialz