Occyo Tele-ophthalmology Study

Last updated: November 19, 2024
Sponsor: Medical University Innsbruck
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vision Loss

Eye Disease

Eye Disorders/infections

Treatment

Ocular surface imaging

Clinical Study ID

NCT06681350
OTS
  • Ages 50-99
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Understands and agrees to comply with the study procedures and provides writteninformed 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

Exclusion Criteria:

  1. Woman of childbearing potential (WOCBP)

Study Design

Total Participants: 365
Treatment Group(s): 1
Primary Treatment: Ocular surface imaging
Phase:
Study Start date:
October 15, 2024
Estimated Completion Date:
October 31, 2026

Connect with a study center

  • Medical University Innsbruck, University Hospital for Ophthalmology and Optometry

    Innsbruck, 6020
    Austria

    Active - Recruiting

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