Occyo Tele-ophthalmology Study

Not Applicable

Recruiting

• Conditions: Cataract

• Registration Number: NCT06681350
• Lead Sponsor: Medical University Innsbruck

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-12
• Study Start: 2024-10-15
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-06
• Study First Posted: 2024-11-08
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-21
• Primary Completion: 2026-10
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 365

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Unexpected Management Changes	1 week	Difference of the detection rate of postoperative complications of cataract surgery defined as any event requiring unexpected management changes (UMC) comparing physical slit lamp examination to independent Occyo One image-based telemedical diagnosis by a blinded examiner.

Secondary Outcome Measures

Name	Time	Method
Efron Grading	1 week	Difference among Efron Grading for ocular redness, derived from physical slit lamp examination versus blinded image-based telemedical assessment of Occyo One photographs. Correlation of Efron Grading of conjunctival redness with objective anterior chamber laser flare photometry.
Oxford Cataract Treatment and Evaluation Team (OCTET) Grading of corneal edema	1 week	Difference among OCTET grading of corneal edema derived from physical slit lamp examination versus blinded image-based telemedical assessment of Occyo One photographs.; Grade Severity Description; 1. mild Transient corneal edema; 2. moderate Transient corneal edema with Descemet's membrane folds of \<10; 3. severe Transient corneal edema with Descemet's membrane folds of \>10
National Eye Institute (NEI) Grading Scale	1 week	Difference among NEI grading score for corneal fluorescein staining derived from physical slit lamp examination versus blinded image-based telemedical assessment of Occyo One photographs.; Each of the 5 areas of the corneal surface are scored and summed to a total score (Grade 0-3).

Trial Locations

Locations (1)

Medical University Innsbruck, University Hospital for Ophthalmology and Optometry; 🇦🇹 Innsbruck, Austria