Anterior Segment of EyeNCT07495345
Feasibility Study of a Novel Automated Slit Lamp Camera (Lightfield Medical Ophthalmic Camera Model Vscan001)
A study testing Lightfield Medical Vscan001 Automated Slit-lamp Camera in people with Anterior Segment of Eye, run by Lightfield Medical at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anterior Segment of Eye
- What is being tested?
- Lightfield Medical Vscan001 Automated Slit-lamp Camera
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2023to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Age younger than 18 years
- Physical inability to position at the device
- Movement disorders that would preclude stable positioning at the device
- Significant photophobia
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Anterior Segment of Eye
- Being tested
- Lightfield Medical Vscan001 Automated Slit-lamp Camera
- Keywords
- Slit-lamp photograph
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lightfield Medical Vscan001 Automated Slit-lamp CameraDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Lightfield Medical Vscan001 Automated Slit-lamp Camera |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During imaging sessions of 5-20 minute duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Jul 2023
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Segment of EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lightfield Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07495345
- Sponsor's protocol ID
- Protocol 001.1
- Other IDs
- 6153
- Status last verified
- Mar 2026
- First submitted
- 14 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of a Novel Automated Slit Lamp Camera (Lightfield Medical Ophthalmic Camera Model Vscan001)
- ClinicalTrials.gov ID
- NCT07495345
- Acronym / sponsor ID
- Protocol 001.1
- Conditions
- Anterior Segment of Eye
- Keywords
- Slit-lamp photograph
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Lightfield MedicalIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Automated Slit-lamp imaging | Experimental | Device: Lightfield Medical Vscan001 Automated Slit-lamp CameraAdult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Age younger than 18 years
- Physical inability to position at the device
- Movement disorders that would preclude stable positioning at the device
- Significant photophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lightfield Medical Vscan001 Automated Slit-lamp CameraThe 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). | Device | Automated Slit-lamp imaging |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No. 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.
Related trials for Anterior Segment of Eye
RecruitingObservational study
PANDA-ASOCT: Paediatric Anterior Uveitis Detection With Automated Image Analysis Using ASOCT
Uveitis
RecruitingObservational study
Agreement of Two OCT Biometers: A Pilot Study
Anterior Segment of Eye, Axial Length
RecruitingObservational study
Multimodal Deep Learning Model for Multi-task Diagnosis and Triage Suggestions of Ophthalmic Diseases
Anterior Segment Diseases
RecruitingObservational study
National Cohort on Congenital Defects of the Eye
Anophthalmia, Microphthalmia
RecruitingObservational study
Development of a Mobile Terminal-Based Intelligent Detection System for Multiple Anterior Segment Diseases of the Eye
Artifical Intelligence, Cataract
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lightfield Medical Vscan001 Automated Slit-lamp Camera in people with Anterior Segment of Eye, run by Lightfield Medical at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Automated Slit-lamp imaging (time frame: During imaging sessions of 5-20 minute duration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.