Feasibility Study of a Novel Automated Slit Lamp Camera (Lightfield Medical Ophthalmic Camera Model Vscan001)

This study evaluated the feasibility of performing automated anterior segment imaging using the Lightfield Medical Vscan001, a novel automated slit lamp camera. The device uses high-speed liquid lens technology to capture slit-illuminated images of the eye that would otherwise require a trained physician or ophthalmic photographer. Adult patients were enrolled at a single ophthalmic practice. The primary objective was to determine what proportion of patients could be successfully imaged with the device in a clinical setting.

Study Overview

• Status: Completed
• Conditions: Anterior Segment of Eye
• Intervention / Treatment: Device: Lightfield Medical Vscan001 Automated Slit-lamp Camera

Detailed Description

The standard ophthalmic slit lamp has remained largely unchanged for over 75 years. Anterior segment photography using conventional slit lamp cameras is limited in practice because it requires a highly trained physician or specialized ophthalmic photographer, captures only a small portion of the exam, and is hindered by difficulty with focus, lighting, and glare artifacts. The Lightfield Medical Vscan001 was developed to address these limitations through automation.

The Vscan001 is a semi-portable, joystick-mounted device with a form factor similar to a conventional slit lamp. It incorporates a 5-megapixel primary camera sensor coupled to a high-speed liquid lens capable of refocusing every 4 milliseconds, enabling automated focus control across the z-axis of the eye. A wide-angle 5-megapixel auxiliary camera provides overview imaging and assists with focus. An LED-based slit projector mounted on a rotating arm illuminates the eye from multiple angles; the projector incorporates a synchronized liquid lens to maintain a focused slit image on ocular structures throughout image acquisition. A microprocessor controls slit movement, slit width, and illumination parameters. Images are stored as Raw and JPEG files on an encrypted hard drive connected via USB to a Windows computer. The device's light energy output meets Group 1 radiant exposure limits as defined by ANSI Z80.36-2016 and qualifies as an FDA Class II exempt device under the PJZ slit lamp camera classification (21 CFR 886.1120). It meets FDA criteria for a non-significant risk (NSR) device under 21 CFR 812.3(m).

The study was conducted in two sequential phases. The Optimization/Calibration Phase involved 5-10 subjects, primarily study personnel and clinic staff volunteers, who underwent longer imaging sessions (5-20 minutes) to optimize camera parameters including shutter speed, aperture, sensor gain, illumination angle, and slit width. The General Recruitment Phase enrolled a larger cohort of adult patients (target 50-200) from Northwest Eye Clinic and its affiliate Minnesota Eye Consultants (Unifeye Vision Partners), Golden Valley, Minnesota. Patients with a range of anterior segment pathology and normal eyes were included to assess feasibility across a broad clinical population.

The primary endpoint was the proportion of enrolled patients who could be successfully imaged with the Vscan001 compared to those who could not - expressed as a simple percentage. A stopping rule was pre-specified: the study would be halted if fewer than 50% of patients could be adequately imaged. Exploratory endpoints included subjective assessment of image quality across varying photographic parameter combinations, with the intent of informing optimal settings for a subsequent pivotal study. No diagnostic or treatment decisions were made based on device output; the device was used solely for photographic documentation.

No randomization, blinding, or control group was employed. Statistical analysis was limited to computation of the primary feasibility proportion. The study was conducted under IRB review by Salus IRB (Austin, TX) and complied with FDA regulations governing non-significant risk device investigations under 21 CFR Part 812.2(b).

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Golden Valley, Minnesota, United States, 55416
      • Northwest Eye

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adults 18 years of age or older
• Ability to position at the device (i.e., ability to rest chin on chinrest and forehead against forehead rest)
• Willingness to provide informed consent
• Patients with or without ocular pathology are eligible

Exclusion Criteria:

• Age younger than 18 years
• Physical inability to position at the device
• Movement disorders that would preclude stable positioning at the device
• Significant photophobia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Automated Slit-lamp imaging; Adult participants underwent anterior segment imaging using the Lightfield Medical Vscan001 automated slit lamp camera. Imaging was performed in a single session lasting approximately 5-20 minutes during the optimization phase and a shorter duration during the general recruitment phase. The device operator positioned participants at the instrument, obtained initial focus via joystick, and activated the automated imaging sequence. The illumination arm was manually positioned through multiple preset angles to capture images from different perspectives. No treatment was administered and no diagnostic decisions were made based on the images obtained.

Device: Lightfield Medical Vscan001 Automated Slit-lamp Camera; The Vscan001 is a semi-portable automated slit lamp camera that captures anterior segment images using high-speed liquid lens technology. The device incorporates a 5-megapixel primary camera sensor with a liquid lens capable of refocusing every 4 milliseconds, a wide-angle 5-megapixel auxiliary camera, and an LED-based slit projector mounted on a rotating arm. A microprocessor controls slit movement, width, and illumination parameters. Participants were seated at the device in a manner similar to a conventional slit lamp examination. The operator obtained initial focus via joystick and activated the automated imaging sequence, manually positioning the illumination arm through multiple preset angles. Images were stored as Raw and JPEG files on an encrypted hard drive. The device qualifies as an FDA Class II exempt device under the PJZ slit lamp camera classification (21 CFR 886.1120) and meets FDA non-significant risk criteria under 21 CFR 812.3(m).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Automated Slit-lamp imaging	The proportion of enrolled participants who could be successfully imaged with the Vscan001 compared to the total number of participants in the General Recruitment phase, expressed as a percentage. Successful imaging was defined as completion of the automated slit lamp imaging sequence with acquisition of usable anterior segment images.	During imaging sessions of 5-20 minute duration

Collaborators and Investigators

• Sponsor: Lightfield Medical

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: March 14, 2026
• First Submitted That Met QC Criteria: March 22, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 22, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Slit-lamp photograph
• Other Study ID Numbers: Protocol 001.1; 6153 (Other Identifier: Salus IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared. This was a small single-site device feasibility study. The dataset is limited in size and scope, and no IPD sharing plan was established prior to study initiation.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No