CataractOTSNCT06681350
Occyo Tele-ophthalmology Study
A study testing Ocular surface imaging in people with Cataract, run by Medical University Innsbruck at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 99 years
- Conditions the study is for
- Cataract
- What is being tested?
- Ocular surface imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 365 participants
- Where
- 1 siteAustria
- Study dates
- 15 Oct 2024to 19 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 1. Woman of childbearing potential (WOCBP)
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University Innsbruck, University Hospital for Ophthalmology and Optometry
Innsbruck, 6020
About this study
Official title: 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.
Read more
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
- Being tested
- Ocular surface imaging
- Keywords
- Cataract, Slit lamp, Telemedical examination, Image based diagnosis
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ocular surface imagingDevice
Telemedical examination of high-resolution, all-in-focus images of the cornea, sclera, conjunctiva, and lid margins for montioring of postoperative complications
| Study group | Role | What they receive |
|---|---|---|
| Occyo One Anterior Segment Imaging | Other | Imaging of the anterior segment of the eye for telemedical assessment. Receives: Device: Ocular surface imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week
Secondary outcomes (3)
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.
Measured: 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
Measured: 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).
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start15 Oct 2024
- Primary completion19 Jun 2026
- Study completion19 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 365 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06681350
- Sponsor's protocol ID
- OTS
- Acronym
- OTS
- Status last verified
- Jun 2026
- First submitted
- 12 Sep 2024
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Diagnostic Effectiveness and Reliability of a Telemedical Examination With Occyo One vs Traditional Slit Lamp-based Examination After Cataract Surgery
- ClinicalTrials.gov ID
- NCT06681350
- Acronym / sponsor ID
- OTS / OTS
- Conditions
- Cataract
- Keywords
- Cataract, Slit lamp, Telemedical examination, Image based diagnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 365 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 19 Jun 2026 (actual)
- Study completion
- 19 Jun 2026 (actual)
- First posted
- 8 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Occyo One Anterior Segment Imaging | Other | Device: Ocular surface imagingImaging of the anterior segment of the eye for telemedical assessment. |
Who may qualify
- Ages
- 50 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 1. Woman of childbearing potential (WOCBP)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ocular surface imagingTelemedical examination of high-resolution, all-in-focus images of the cornea, sclera, conjunctiva, and lid margins for montioring of postoperative complications | Device | Occyo One Anterior Segment Imaging |
Primary outcome
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.
3 secondary outcomes
Efron Grading
Time frame: 1 week
Oxford Cataract Treatment and Evaluation Team (OCTET) Grading of corneal edema
Time frame: 1 week
National Eye Institute (NEI) Grading Scale
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ocular surface imaging in people with Cataract, run by Medical University Innsbruck at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unexpected Management Changes (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.