Apple Vision Pro for Cataracts

TK
BS
Overseen ByBishoy Said, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Sharp HealthCare
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how the Apple Vision Pro headset aids doctors during eye surgeries, such as cataract surgery. Researchers aim to determine if the headset improves the surgical process, making it smoother and safer for both doctors and patients. Individuals scheduled for elective eye surgeries who can provide consent may be suitable candidates for this trial. As an unphased trial, participation offers an opportunity to contribute to innovative research that could enhance surgical outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Apple Vision Pro and Zeiss Artevo Digital Surgical Microscope are safe for use in cataract surgery?

Research has shown that the Apple Vision Pro is easy to use and effective during surgeries. In a small study, surgeons used it throughout their operations and found it practical and straightforward, suggesting its safety in surgical settings.

The Zeiss Artevo Digital Surgical Microscope has even stronger evidence supporting its safety. The FDA has approved it, confirming its safety and effectiveness. A study found that surgeries using a similar model, the Artevo 800, were completed successfully without any issues.

Both devices appear safe based on current research. However, discussing any concerns with the study team before joining a trial is always important.12345

Why are researchers excited about this trial?

Researchers are excited about using the Apple Vision Pro for cataract surgery because it introduces spatial computing visualization to the operating room. Unlike traditional methods that rely on microscopes and surgical loupes, this cutting-edge technology allows surgeons to visualize the surgery in 3D with a head-mounted display, offering a more immersive and detailed view of the eye. This could lead to enhanced precision and potentially better surgical outcomes. By integrating advanced digital visualization, the Apple Vision Pro aims to revolutionize how eye surgeries are performed, making them more effective and efficient.

What evidence suggests that the Apple Vision Pro and Zeiss Artevo Digital Surgical Microscope are effective for cataract surgery?

Studies have shown that the Apple Vision Pro is effective in eye surgeries, with surgeons rating it highly for ease of use. It provides a more immersive view of the surgical area, potentially enhancing precision during procedures. The Zeiss Artevo 850 digital microscope, known for its advanced 3D imaging, aids surgeons in clearly viewing the eye during operations. This trial will use the Apple Vision Pro for spatial computing visualization in cataract and anterior segment eye surgery. Although this trial lacks a comparison group, early research suggests that combining these technologies could streamline the surgery process and enhance the experience for both surgeons and patients.14567

Who Is on the Research Team?

TK

Tommy Korn, MD

Principal Investigator

Sharp Rees-Stealy Medical Group and Sharp HealthCare

Are You a Good Fit for This Trial?

This trial is for adults aged 18 or older who are scheduled for elective eye surgery, such as cataract surgery. Participants must be able to understand and agree to the study's procedures.

Inclusion Criteria

I am scheduled for eye surgery, such as cataract removal.
I am 18 years old or older.
I am willing and able to give my consent to participate.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Treatment

Participants undergo standard-of-care cataract or anterior segment ocular surgery with adjunctive use of head-mounted spatial computing visualization

Perioperative
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Immediately after surgery
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Apple Vision Pro
  • Zeiss Artevo Digital Surgical Microscope

Trial Overview

Researchers are testing a new device called Apple Vision Pro, which is worn on the head for better viewing during eye surgery. It's used alongside the Zeiss Artevo microscope to see if it improves surgical workflow and safety.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Spatial computing visualization of cataract and anterior segment eye surgeryExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sharp HealthCare

Lead Sponsor

Trials
42
Recruited
17,600+

Citations

Evaluation of Head-Mounted Spatial Computing and Three ...

The purpose of this research is to evaluate the use of the research study device, the Apple Vision Pro head-mounted spatial computing display, ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39140319/

Utilization of apple vision pro in ophthalmic surgery: A pilot ...

Results: The surgeons used the Apple Vision Pro during the entire procedure, and the results were positive, with high ratings for practicality, ...

Apple Vision Pro for Cataracts · Info for Participants

The purpose of this research is to evaluate the use of the research study device, the Apple Vision Pro head-mounted spatial computing display, ...

Utilization of apple vision pro in ophthalmic surgery: A pilot ...

Results The surgeons used the Apple Vision Pro during the entire procedure, and the results were positive, with high ratings for practicality, freedom of ...

Cataract in the Adult Eye Preferred Practice Pattern

Cataract surgery for these patients results in a greater improvement in functional vision than surgery in binocularly sighted patients.

Ophthalmic Telesurgery with a Low-Cost Smartphone Video ...

The study's aim was to evaluate the potential of smartphone-captured surgical videos for surgeon learning via self-recording and self-review.

AR/VR and the Future of Ophthalmology

This article explores the world of AR/VR, including the Vision Pro, and what it may signal for the future of ophthalmology.