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

NCT07495345 | Completed DMC FDA Device

• 2 other identifiers: Protocol 001.16153
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anterior Segment of Eye

Keywords

Slit-lamp photograph

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Automated Slit-lamp imaging

EXPERIMENTAL

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

Interventions

Lightfield Medical Vscan001 Automated Slit-lamp Camera DEVICE

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).

Automated Slit-lamp imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Lightfield Medical: lead

Study Sites (1)

Northwest Eye

Golden Valley, Minnesota, 55416, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All enrolled participants underwent anterior segment imaging with the Lightfield Medical Vscan001 automated slit lamp camera. No comparator device, control group, or randomization was employed. Participants were assessed solely on their ability to be successfully imaged with the device. This study was conducted to evaluate the clinical feasibility of automated anterior segment imaging using an investigational slit lamp camera across a range of patients with and without ocular pathology. The objective was to determine the proportion of patients who could be successfully imaged in a real-world clinical setting and to optimize photographic parameters for use in future studies. While the study is exploratory in nature, it exceeds the participant threshold for the "Device Feasibility" designation and is not a pivotal efficacy or diagnostic accuracy trial.

Study Record Dates

• First Submitted: March 14, 2026
• First Posted: March 27, 2026
• Study Start: July 1, 2023
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)