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Completed

NCT Number: NCT06681350

Occyo Tele-ophthalmology Study

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

50 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University Innsbruck, University Hospital for Ophthalmology and Optometry

Innsbruck, 6020, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Woman of childbearing potential (WOCBP)

Treatment and study plan

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

Primary outcomes

  1. Unexpected Management Changes

    Time frame: 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 outcomes

  1. Efron Grading

    Time frame: 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.

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

    Time frame: 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

    • 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

  3. National Eye Institute (NEI) Grading Scale

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Medical University Innsbruck

Other

Registry information

Official study title

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

Acronym: OTS

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 8, 2024
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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