Cataract SurgeryNCT07301385
Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study
A study testing Apple Vision Pro (Head-Mounted Spatial Computing Display) and Zeiss Artevo Digital Surgical Microscope in people with Cataract Surgery and Cataract, run by Sharp HealthCare at 1 site in United States.
Trial summary
The purpose of this research is to evaluate the use of the research study device, the Apple Vision Pro head-mounted spatial computing display, with the Zeiss Artevo 850 digital microscope system, for the visualization during cataract and anterior segment surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract Surgery, Cataract
- What is being tested?
- Apple Vision Pro (Head-Mounted Spatial Computing Display) and Zeiss Artevo Digital Surgical Microscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2026to 11 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older
- Scheduled to undergo elective anterior segment eye surgery, including: cataract surgery, pterygium excision, corneal epithelial polishing
- Able and willing to provide informed consent prior to participation.
Who cannot join
- Complex ocular pathology that could interfere with surgical visualization or increase procedural risk, including but not limited to:
- Lens zonular instability or phacodonesis
- Prior vitreoretinal surgery (e.g., vitrectomy, scleral buckle, glaucoma drainage device) in the operative eye
- Significant corneal scarring, opacity, or edema
- Active ocular surface inflammation or infection
- Cognitive impairment or language barriers that prevent the patient from understanding and signing informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sharp Otay Lakes Surgery Center
San Diego, California, 91914
About this study
Official title: Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Feasibility and Safety Study
The purpose of this research is to evaluate the use of the research study device, the Apple Vision Pro head-mounted spatial computing display, with the Zeiss Artevo 850 digital microscope system, for the visualization during cataract and anterior segment surgery. Specifically, researchers will assess how the study device affects surgical staff experience and workflow and monitor for patient safety and intraoperative complications associated with the use of the device.
Read the detailed description
Surgeons and operating room staff will be asked to complete a survey regarding workflow, setup, and communication immediately after the procedure.
- Conditions
- Cataract Surgery, Cataract
- Being tested
- Apple Vision Pro (Head-Mounted Spatial Computing Display), Zeiss Artevo Digital Surgical Microscope
- Keywords
- ocular microsurgery, spatial computing, eye surgery, Cataract surgery
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apple Vision Pro (Head-Mounted Spatial Computing Display)Device
Head-mounted spatial computing display used by the surgeon to view the real-time video output from the Zeiss Artevo digital surgical microscope. The Apple Vision Pro functions solely as an alternative visualization interface and does not acquire images, alter microscope function, modify surgical technique, or affect patient care.
Zeiss Artevo Digital Surgical MicroscopeDevice
FDA-cleared digital ophthalmic surgical microscope used as standard of care to visualize the operative eye during cataract and anterior segment surgery. The microscope provides the primary intraoperative imaging source for all cases, regardless of visualization display method.
| Study group | Role | What they receive |
|---|---|---|
| Spatial computing visualization of cataract and anterior segment eye surgery | Experimental | Participants undergo standard-of-care cataract or anterior segment ocular surgery with adjunctive use of head-mounted spatial computing visualization. There is no comparison group. Receives: Device: Apple Vision Pro (Head-Mounted Spatial Computing Display); Device: Zeiss Artevo Digital Surgical Microscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative safety during head-mounted spatial computing visualization
Safety will be assessed by the proportion of surgical cases completed using head-mounted spatial computing visualization without conversion to standard microscope visualization due to device-related issues, and by the occurrence of intraoperative complications potentially related to visualization, including posterior capsule rupture, vitreous loss, corneal or scleral injury, or other unplanned intraoperative events.
Measured: Perioperative
Secondary outcomes (4)
Surgeon workload during ocular surgery
Surgeon workload measured using the National Aeronautics and Space Administration Task Load Index (NASA-TLX) questionnaire completed by the operating surgeon.
Measured: Immediately after surgery
Surgeon-reported visualization quality and ergonomics
Surgeon-reported assessment of visualization clarity, comfort, ergonomic strain, and overall usability using a post-procedure survey.
Measured: Immediately after surgery
Operating room staff workflow and usability
Operating room staff perception of workflow, communication, setup efficiency, and usability assessed using a post-procedure survey.
Measured: Immediately after surgery
Operative time and setup efficiency
Total operative time and setup duration recorded from the electronic medical record and intraoperative documentation.
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start11 Mar 2026
- Primary completion11 Jun 2026
- Study completion11 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cataract SurgeryStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The primary purpose of this study is to evaluate the safety and workflow impact of adjunctive head-mounted spatial computing visualization during standard-of-care ocular microsurgery. All enrolled participants undergo standard-of-care ocular microsurgery with adjunctive use of a head-mounted spatial computing visualization device. There is no comparison group.
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sharp HealthCare
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tommy Korn, MD, Sharp HealthCare
- Investigators
- Tommy Korn, MD, Principal investigator, Sharp Rees-Stealy Medical Group and Sharp HealthCare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07301385
- Sponsor's protocol ID
- Spatial Ocular Microsurgery
- Status last verified
- Jun 2026
- First submitted
- 6 Dec 2025
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: IPD will not be shared to protect patient confidentiality. Only aggregated, de-identified data will be published in scientific reports on visualization performance, workflow, and surgeon and operating room staff feedback.
Publications
Brooke, J. (1996). SUS: A quick and dirty usability scale. In P. W. Jordan, B. Thomas, B. A. Weerdmeester, & I. L. McClelland (Eds.), Usability Evaluation in Industry (pp. 189-194). London: Taylor & Francis.
Hart, S. G., & Staveland, L. E. (1988). Development of NASA-TLX (Task Load Index): Results of empirical and theoretical research. In P. A. Hancock & N. Meshkati (Eds.), Human Mental Workload (pp. 139-183). Amsterdam: North-Holland.
Mastropasqua R, Ruggeri ML, Quarta A, Tartaro R, Vecchiarino L, Corboli LV, Brescia L, Orione M, Russo A, Avitabile T, Mastropasqua L. New Mixed Reality Headset: First Exploratory Use in Intraocular Surgery and Telementoring. Ophthalmol Ther. 2025 Jul;14(7):1597-1609. doi: 10.1007/s40123-025-01117-y. Epub 2025 Apr 11.
PubMed 40214829Broderick RC, Spurzem GJ, Jeffery Reeves J, Hollandsworth HM, Sandler BJ, Jacobsen GR, Longhurst CA, Horgan S. First use of augmented reality headset in minimally invasive general surgery: seeing is believing. Surg Endosc. 2025 Sep;39(9):6055-6060. doi: 10.1007/s00464-025-11985-x. Epub 2025 Jul 10.
PubMed 40640628Suh Y, Shin S, Kim BY, Jeong J, Kim TI. Comparison of neck angle and musculoskeletal discomfort of surgeon in cataract surgery between three-dimensional heads-up display system and conventional microscope. Sci Rep. 2024 Sep 30;14(1):22681. doi: 10.1038/s41598-024-68630-1.
PubMed 39349516
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Feasibility and Safety Study
- ClinicalTrials.gov ID
- NCT07301385
- Acronym / sponsor ID
- Spatial Ocular Microsurgery
- Conditions
- Cataract Surgery, Cataract
- Keywords
- ocular microsurgery, spatial computing, eye surgery, Cataract surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Sharp HealthCareUniversity, hospital or other
- Study start
- 11 Mar 2026 (actual)
- Primary completion
- 11 Jun 2026 (actual)
- Study completion
- 11 Jun 2026 (actual)
- First posted
- 24 Dec 2025 (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 purpose of this research is to evaluate the use of the research study device, the Apple Vision Pro head-mounted spatial computing display, with the Zeiss Artevo 850 digital microscope system, for the visualization during cataract and anterior segment surgery. Specifically, researchers will assess how the study device affects surgical staff experience and workflow and monitor for patient safety and intraoperative complications associated with the use of the device.
Detailed description
Surgeons and operating room staff will be asked to complete a survey regarding workflow, setup, and communication immediately after the procedure.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The primary purpose of this study is to evaluate the safety and workflow impact of adjunctive head-mounted spatial computing visualization during standard-of-care ocular microsurgery. All enrolled participants undergo standard-of-care ocular microsurgery with adjunctive use of a head-mounted spatial computing visualization device. There is no comparison group.
| Arm | Type | Receives |
|---|---|---|
| Spatial computing visualization of cataract and anterior segment eye surgery | Experimental | Device: Apple Vision Pro (Head-Mounted Spatial Computing Display), Device: Zeiss Artevo Digital Surgical MicroscopeParticipants undergo standard-of-care cataract or anterior segment ocular surgery with adjunctive use of head-mounted spatial computing visualization. There is no comparison group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18 years or older
- Scheduled to undergo elective anterior segment eye surgery, including: cataract surgery, pterygium excision, corneal epithelial polishing
- Able and willing to provide informed consent prior to participation.
Key exclusion criteria (6 listed)
- Complex ocular pathology that could interfere with surgical visualization or increase procedural risk, including but not limited to:
- Lens zonular instability or phacodonesis
- Prior vitreoretinal surgery (e.g., vitrectomy, scleral buckle, glaucoma drainage device) in the operative eye
- Significant corneal scarring, opacity, or edema
- Active ocular surface inflammation or infection
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 |
|---|---|---|
| Apple Vision Pro (Head-Mounted Spatial Computing Display)Head-mounted spatial computing display used by the surgeon to view the real-time video output from the Zeiss Artevo digital surgical microscope. The Apple Vision Pro functions solely as an alternative visualization interface and does not acquire images, alter microscope function, modify surgical technique, or affect patient care. | Device | Spatial computing visualization of cataract and anterior segment eye surgery |
| Zeiss Artevo Digital Surgical MicroscopeFDA-cleared digital ophthalmic surgical microscope used as standard of care to visualize the operative eye during cataract and anterior segment surgery. The microscope provides the primary intraoperative imaging source for all cases, regardless of visualization display method. | Device | Spatial computing visualization of cataract and anterior segment eye surgery |
Primary outcome
Intraoperative safety during head-mounted spatial computing visualization
Time frame: Perioperative
Safety will be assessed by the proportion of surgical cases completed using head-mounted spatial computing visualization without conversion to standard microscope visualization due to device-related issues, and by the occurrence of intraoperative complications potentially related to visualization, including posterior capsule rupture, vitreous loss, corneal or scleral injury, or other unplanned intraoperative events.
4 secondary outcomes
Surgeon workload during ocular surgery
Time frame: Immediately after surgery
Surgeon-reported visualization quality and ergonomics
Time frame: Immediately after surgery
Operating room staff workflow and usability
Time frame: Immediately after surgery
Operative time and setup efficiency
Time frame: Perioperative
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 24 Jun 2026.
- BackgroundBrooke, J. (1996). SUS: A quick and dirty usability scale. In P. W. Jordan, B. Thomas, B. A. Weerdmeester, & I. L. McClelland (Eds.), Usability Evaluation in Industry (pp. 189-194). London: Taylor & Francis.
- BackgroundHart, S. G., & Staveland, L. E. (1988). Development of NASA-TLX (Task Load Index): Results of empirical and theoretical research. In P. A. Hancock & N. Meshkati (Eds.), Human Mental Workload (pp. 139-183). Amsterdam: North-Holland.
- Background: PubMed 40214829Mastropasqua R, Ruggeri ML, Quarta A, Tartaro R, Vecchiarino L, Corboli LV, Brescia L, Orione M, Russo A, Avitabile T, Mastropasqua L. New Mixed Reality Headset: First Exploratory Use in Intraocular Surgery and Telementoring. Ophthalmol Ther. 2025 Jul;14(7):1597-1609. doi: 10.1007/s40123-025-01117-y. Epub 2025 Apr 11.
- Background: PubMed 40640628Broderick RC, Spurzem GJ, Jeffery Reeves J, Hollandsworth HM, Sandler BJ, Jacobsen GR, Longhurst CA, Horgan S. First use of augmented reality headset in minimally invasive general surgery: seeing is believing. Surg Endosc. 2025 Sep;39(9):6055-6060. doi: 10.1007/s00464-025-11985-x. Epub 2025 Jul 10.
- Background: PubMed 39349516Suh Y, Shin S, Kim BY, Jeong J, Kim TI. Comparison of neck angle and musculoskeletal discomfort of surgeon in cataract surgery between three-dimensional heads-up display system and conventional microscope. Sci Rep. 2024 Sep 30;14(1):22681. doi: 10.1038/s41598-024-68630-1.
- Individual participant dataSharing planned: No. IPD will not be shared to protect patient confidentiality. Only aggregated, de-identified data will be published in scientific reports on visualization performance, workflow, and surgeon and operating room staff feedback.
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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.
Tommy Korn, MD principal investigator
Sharp Rees-Stealy Medical Group and Sharp HealthCare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apple Vision Pro (Head-Mounted Spatial Computing Display) and Zeiss Artevo Digital Surgical Microscope in people with Cataract Surgery and Cataract, run by Sharp HealthCare at 1 site in United States.
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 6 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 24 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 United States. 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?
Intraoperative safety during head-mounted spatial computing visualization (time frame: Perioperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07301385, which also lists 5 linked publications.
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 24 Jun 2026.