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

Conditions

• Anterior Segment of Eye

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

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).

Study Details

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.

Key Dates

Start date

Jul 1, 2023

Status verified

Mar 2026

Primary completion

Sep 30, 2024

Completion

Sep 30, 2024

Study Design

Enrollment

54 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Arms

• 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.

Primary Outcome Measure

Feasibility of Automated Slit-lamp imaging [ Time Frame: During imaging sessions of 5-20 minute duration ]

Locations (1)

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