Cataract SurgeryNCT07825337
Pilot Study: Feasibility and Usability of a Head-Mounted Spatial Computing Device for Intraoperative Visualization During Intraocular Surgery
An observational study of Cataract Surgery, run by Eric Rosenberg at 1 site in United States.
Trial summary
To evaluate the feasibility and usability of Apple Vision Pro as an adjunct visualization and information display tool during ophthalmic surgery. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cataract Surgery
- What is being tested?
- Apple Vision Pro Visualization System
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2026to 30 Aug 2028
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any patient having surgery performed who meets the inclusionary/exclusionary criteria at the Long Island Ambulatory Surgery Center, Brentwood, NY 11717
Who may be able to join
- Adults aged 18 years or older.
- Undergoing clinically indicated, elective ophthalmic surgery (e.g., cataract, anterior segment, retina) at a participating study site.
- Able and willing to provide informed consent prior to participation.
Who cannot join
- Prisoners or other vulnerable populations, unless specifically justified and approved by the IRB.
- Inability to provide consent and no legally authorized representative available.
- Cognitive impairment or language barriers precluding understanding of the consent, in the absence of a legally authorized representative.
- Procedures where any additional OR equipment is judged by the surgeon to pose unacceptable risk.
- Complex ocular pathology that could interfere with surgical visualization or increase procedural risk, including but not limited to lenticular zonule instability, previous ophthalmic surgery, corneal scarring, corneal opacity or edema, or active ocular surface infection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Long Island Ambulator Surgery Center
Brentwood, New York, 11717
Donna Casserly, RN, 6316122722, Donnac@liasc.net
About this study
To evaluate the feasibility and usability of Apple Vision Pro as an adjunct visualization and information display tool during ophthalmic surgery.
Read the detailed description
This is a prospective, observational, single-arm feasibility and usability study. Eligible adult patients undergoing clinically indicated intraocular surgery will have their surgeries performed according to standard of care, while the attending surgeon optionally uses Apple Vision Pro as an adjunct visualization device. No experimental procedures are performed on the patient, and standard microscopes and displays remain the primary visualization method. Approximately 40-70 surgeries will be observed across participating sites. Data will be collected intraoperatively and immediately postoperatively from the surgical record and from surgeon questionnaires.
- Conditions
- Cataract Surgery
- Being tested
- Apple Vision Pro Visualization System
- Keywords
- Spatial computing, Augmented Reality, Cataract Surgery, Apple Vision Pro, Heads-up Display
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apple Vision Pro Visualization SystemDevice
Apple Vision Pro as an adjunct intraoperative visualization and information display tool during ophthalmic surgery.[
| Study group | Role | What they receive |
|---|---|---|
| Patient undergoing cataract surgery | Cataract surgery patients Receives: Device: Apple Vision Pro Visualization System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuity of care
Completion of surgery without device-related interruption that requires abandoning the surgery or conversion to an alternative procedure.
Measured: 1 year
Questionnaire
XR Usability Questionnaire (XR-UQ) scores for each case.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start30 Aug 2026
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Eric Rosenberg
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Eric Rosenberg, ScopeXR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07825337
- Sponsor's protocol ID
- 1408687
- Status last verified
- Sep 2026
- First submitted
- 30 Aug 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Novel technology with limited surgeons using 3D digital microscopes.
Publications
Orione M, Rubegni G, Tartaro R, Alberghina A, Fallico M, Orione C, Russo A, Tosi GM, Avitabile T. Utilization of apple vision pro in ophthalmic surgery: A pilot study. Eur J Ophthalmol. 2025 Mar;35(2):715-721. doi: 10.1177/11206721241273574. Epub 2024 Aug 14.
PubMed 39140319
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Feasibility and Usability of a Head-Mounted Spatial Computing Device for Intraoperative Visualization During Intraocular Surgery
- ClinicalTrials.gov ID
- NCT07825337
- Acronym / sponsor ID
- 1408687
- Conditions
- Cataract Surgery
- Keywords
- Spatial computing, Augmented Reality, Cataract Surgery, Apple Vision Pro, Heads-up Display
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Eric RosenbergIndustry (pharma, biotech, devices)
- Study start
- 30 Aug 2026 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Aug 2028 (estimated)
- First posted
- 17 Sep 2026 (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.
To evaluate the feasibility and usability of Apple Vision Pro as an adjunct visualization and information display tool during ophthalmic surgery.
Detailed description
This is a prospective, observational, single-arm feasibility and usability study. Eligible adult patients undergoing clinically indicated intraocular surgery will have their surgeries performed according to standard of care, while the attending surgeon optionally uses Apple Vision Pro as an adjunct visualization device. No experimental procedures are performed on the patient, and standard microscopes and displays remain the primary visualization method. Approximately 40-70 surgeries will be observed across participating sites. Data will be collected intraoperatively and immediately postoperatively from the surgical record and from surgeon questionnaires.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient undergoing cataract surgery | – | Device: Apple Vision Pro Visualization SystemCataract surgery patients |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient having surgery performed who meets the inclusionary/exclusionary criteria at the Long Island Ambulatory Surgery Center, Brentwood, NY 11717
Key inclusion criteria (3 listed)
- Adults aged 18 years or older.
- Undergoing clinically indicated, elective ophthalmic surgery (e.g., cataract, anterior segment, retina) at a participating study site.
- Able and willing to provide informed consent prior to participation.
Key exclusion criteria (5 listed)
- Prisoners or other vulnerable populations, unless specifically justified and approved by the IRB.
- Inability to provide consent and no legally authorized representative available.
- Cognitive impairment or language barriers precluding understanding of the consent, in the absence of a legally authorized representative.
- Procedures where any additional OR equipment is judged by the surgeon to pose unacceptable risk.
- Complex ocular pathology that could interfere with surgical visualization or increase procedural risk, including but not limited to lenticular zonule instability, previous ophthalmic surgery, corneal scarring, corneal opacity or edema, or active ocular surface 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 Visualization SystemApple Vision Pro as an adjunct intraoperative visualization and information display tool during ophthalmic surgery.[ | Device | Patient undergoing cataract surgery |
Primary outcome
Continuity of care
Time frame: 1 year
Completion of surgery without device-related interruption that requires abandoning the surgery or conversion to an alternative procedure.
Questionnaire
Time frame: 1 year
XR Usability Questionnaire (XR-UQ) scores for each case.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Results publication: PubMed 39140319Orione M, Rubegni G, Tartaro R, Alberghina A, Fallico M, Orione C, Russo A, Tosi GM, Avitabile T. Utilization of apple vision pro in ophthalmic surgery: A pilot study. Eur J Ophthalmol. 2025 Mar;35(2):715-721. doi: 10.1177/11206721241273574. Epub 2024 Aug 14.
- Individual participant dataSharing planned: No. Novel technology with limited surgeons using 3D digital microscopes.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract Surgery, run by Eric Rosenberg 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 5 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: looking for participants now, as of the sponsor's last update on 17 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kathy Lemier (6319573355, eric@scopeXR.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuity of care (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT07825337, which also lists 1 linked publication.
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 17 Sep 2026.