Occyo Tele-ophthalmology Study (OTS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cataract
• Intervention / Treatment: Device: Ocular surface imaging

• Study Type: Interventional
• Enrollment (Estimated): 365
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christoph Palme, Dr.; Phone Number: +43 (0)512 504-23720; Email: lki.augen-studienzentrale@tirol-kliniken.at

Study Locations

• Austria
  • Innsbruck, Austria, 6020
    • Recruiting
    • Medical University Innsbruck, University Hospital for Ophthalmology and Optometry
    • Contact: Christoph Palme, Dr.; Phone Number: +43 (0)512/504-23720; Email: lki.augen-studienzentrale@tirol-kliniken.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Occyo One Anterior Segment Imaging; Imaging of the anterior segment of the eye for telemedical assessment.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unexpected Management Changes	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.	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efron Grading	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.	1 week
Oxford Cataract Treatment and Evaluation Team (OCTET) Grading of corneal edema	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; mild Transient corneal edema; moderate Transient corneal edema with Descemet's membrane folds of <10; severe Transient corneal edema with Descemet's membrane folds of >10	1 week
National Eye Institute (NEI) Grading Scale	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).	1 week

Collaborators and Investigators

• Sponsor: Medical University Innsbruck

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: September 12, 2024
• First Submitted That Met QC Criteria: November 6, 2024
• First Posted (Actual): November 8, 2024

Study Record Updates

• Last Update Posted (Estimated): November 21, 2024
• Last Update Submitted That Met QC Criteria: November 19, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Cataract; Slit lamp; Telemedical examination; Image based diagnosis
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: OTS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No