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

March 22, 2026 updated by: Lightfield Medical
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility of Automated Slit-lamp imaging
Time Frame: During imaging sessions of 5-20 minute duration
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lightfield Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 14, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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