NCT06681350

Occyo Tele-ophthalmology Study

Evaluation of Diagnostic Effectiveness and Reliability of a Telemedical Examination with Occyo One Vs Traditional Slit Lamp-based Examination After Cataract Surgery

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 365 (estimated)
• Sponsor: Medical University Innsbruck · Academic / Other
• Sex: All
• Age: 50 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cataract

Interventions

Type	Name	Description
DEVICE	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

Timeline

• Start date: 2024-10-15
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2024-11-08
• Last updated: 2024-11-21

Locations

1 site across 1 country: Austria