Eye Gaze Guidance Evaluation in Phantoms
NCT07174479 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2026-05-22
Summary
This project aims to develop an augmented reality (AR) tool to enhance skill acquisition for endoscopic kidney stone surgery. Of the 100,000 patients who undergo an endoscopic kidney stone treatment annually in the United States, 25% will require a repeat stone surgery within 20 months of their index surgery. The repeat stone surgery rate is almost completely driven by postoperative residual stone fragments, which lead to ureteral obstruction, causing pain, urinary tract infection, and kidney injury. One significant factor that contributes to residual stone fragments is limited visualization of the entire collecting system - a skill directly associated with surgeon experience. This leads to novice surgeons having a much higher recurrence rate than experienced ones. As the incidence of kidney stone disease continues to increase (prevalence of 10%, incidence of 1116 per 100,000), improved endoscopic surgical training is required to improve outcomes of stone surgeries and minimize complications by improving stone-free rate.
Currently, skill assessment during endoscopic stone surgery is limited. There are no objective metrics for endoscopic surgery to assess skill. The only feedback trainees get is in the form of verbal communication from expert surgeons, usually after the conclusion of surgery. Thus, most feedback is synoptic and limited in facilitating skill acquisition. Operative time and patient safety concerns restrict the amount of active, real-time feedback given during a case for skill acquisition. Endoscopic kidney stone surgery is uniquely challenging given the small depth and field of view of current endoscopes, which complicate the complete visualization of the entire collecting system.
Navigation of the collecting system relies on mentally mapping preoperative imaging to the endoscopic surgical field. Success in mapping relies on hand-eye coordination, memory, and spatial reasoning, which are gained through practice. Thus, there is a need for tools that facilitate endoscopic surgical skill acquisition.
The overarching hypothesis for this research is that surgical skill acquisition and outcomes for endoscopic kidney stone surgery can be improved by analyzing eye gaze data and using expert gaze to guide surgical trainees intraoperatively. Eye gaze guidance has been shown to lead to better skill acquisition in virtual reality surgical tasks compared with motion guidance alone. The proposed system would provide real-time education for trainees during endoscopic stone surgery, such as through head-mounted displays (i.e., the Microsoft HoloLens 2). The investigators have previously demonstrated eye gaze sharing in phantoms. By implementing this system in the operating room (OR), the investigators would be able to instill durable skill acquisition in trainees.
Conditions
- Kidney Stones
Interventions
- DEVICE
-
Augmented reality
Augmented reality markers show the surgical trainee the expert's gaze location during the kidney exploration phase of surgery.
Sponsors & Collaborators
-
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
collaborator NIH -
Vanderbilt University
collaborator OTHER -
Vanderbilt University Medical Center
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- DEVICE_FEASIBILITY
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-02-21
- Primary Completion
- 2025-11-03
- Completion
- 2025-11-03
Countries
- United States
Study Locations
More Related Trials
-
Virtual Reality Mobility Assessment of Functional Vision in Retinal Disease
NCT04289571 ·Status: RECRUITING ·Phase: PHASE1
-
An Exploratory Study of Visual Function Rehabilitation in Patients With Ocular Trauma
NCT06174415 ·Status: UNKNOWN ·Phase: NA
-
Intraoperative Optical Coherence Tomography for Ophthalmic Surgical Guidance - Cornea
NCT05210478 ·Status: NOT_YET_RECRUITING
-
Adaptive Optics Retinal Imaging
NCT02317328 ·Status: RECRUITING
-
Computer-Assisted Rehabilitation Environment Training After Argus Retinal Prosthesis
NCT03444961 ·Status: COMPLETED ·Phase: NA
-
A Virtual Reality Platform Simulating Visual Impairment for Testing of Electronic Travel Aids and Performing Orientation and Mobility Training
NCT05135195 ·Status: COMPLETED ·Phase: NA
-
Photobiomodulation for Dry Age Related Macula Degeneration
NCT05507840 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Visual Field Analysis With Artificial Intelligence
NCT06920290 ·Status: ACTIVE_NOT_RECRUITING
-
A Study to Evaluate the Safety and Performance of the Vista Probe for Vitrectomy Surgery
NCT05689333 ·Status: COMPLETED ·Phase: NA
-
Home OCT Fluid Visualization Agreement Study
NCT04907409 ·Status: UNKNOWN
-
Development of an Optimal Algorithm for the Management of Patients With Retinal Pigment Epithelium Detachment in Neovascular Age-related Macular Degeneration Using Artificial Intelligence
NCT05208931 ·Status: COMPLETED
-
Observational Study to Assess Endpoint Operational Feasibility & Measurement Properties in Patients with Retinal Degeneration
NCT06375239 ·Status: RECRUITING
-
Simulator Training for Direct Ophthalmoscopy
NCT04157023 ·Status: COMPLETED ·Phase: NA
-
Multimodal Imaging in Vitreo-retinal Surgery and Macular Dystrophies
NCT05747144 ·Status: RECRUITING
-
User-centric Study of Patients' Receptiveness Towards the Web-based Automated Vision Impairment Gaze-tracking Analysis Systems
NCT07338513 ·Status: NOT_YET_RECRUITING
-
Contactless Optical Monitoring of AV Access Using the PatenSee System in Outpatient Hemodialysis Patients
NCT07194395 ·Status: RECRUITING
-
Assessment of Retinal Fundus Imaging Camera
NCT06173232 ·Status: RECRUITING
-
AI-Assisted Detection of Posterior Segment Diseases: DR, AMD, RVO, and Glaucoma
NCT07318428 ·Status: ENROLLING_BY_INVITATION ·Phase: NA
-
High Resolution Retina Imaging
NCT04128150 ·Status: UNKNOWN
-
Developing Better Computerised Vision Tests (CVTV)
NCT06224751 ·Status: RECRUITING
-
Validation of the Utility of Ophthalmology Intelligent Diagnostic System
NCT03499145 ·Status: COMPLETED
-
ARDA Software for the Detection of mtmDR
NCT04905459 ·Status: COMPLETED
-
Point-of-Care Ophthalmic Diagnostic Imaging of Retinopathy of Prematurity
NCT06612541 ·Status: RECRUITING
-
Optical Coherence Tomography Angiography in Subjects With Retinal Vascular Disease
NCT04505618 ·Status: RECRUITING ·Phase: NA
-
Therapy of Age-related Macular Degeneration
NCT05222997 ·Status: UNKNOWN