Occyo Tele-ophthalmology Study

NCT06681350 | Completed

• 1 other identifier: OTS
• Study Type: interventional
• Target: 365
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract

Keywords

Cataract; Slit lamp; Telemedical examination; Image based diagnosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Efron Grading

  1 week

• Oxford Cataract Treatment and Evaluation Team (OCTET) Grading of corneal edema

  1 week

• National Eye Institute (NEI) Grading Scale

  1 week

Study Arms (1)

Occyo One Anterior Segment Imaging

OTHER

Imaging of the anterior segment of the eye for telemedical assessment.

Device: Ocular surface imaging

Interventions

Ocular surface imaging DEVICE

Telemedical examination of high-resolution, all-in-focus images of the cornea, sclera, conjunctiva, and lid margins for montioring of postoperative complications

Occyo One Anterior Segment Imaging

Eligibility Criteria

• Age: 50 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ≥ 50 years at time of consent

You may not qualify if:

• \. Woman of childbearing potential (WOCBP)

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (1)

Medical University Innsbruck, University Hospital for Ophthalmology and Optometry

Innsbruck, 6020, Austria

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: November 8, 2024
• Study Start: October 15, 2024
• Primary Completion: June 19, 2026
• Study Completion: June 19, 2026
• Last Updated: June 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)