Eye DiseasesWiSLONCT06177639
Widefield Confocal Scanning Laser Ophthalmoscope Optimized for Pediatric and Neonatal Imaging
An observational study of Eye Diseases, run by Duke University at 1 site in United States.
Trial summary
The goal of this observational study is to test the use of a novel Widefield Confocal Scanning Laser Ophthalmoscope (WiSLO) Optimized for Pediatric and Neonatal Imaging in pediatric and adult subjects who are undergoing clinical evaluation for eye disease or are healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 30 days and olderHealthy volunteers can take part
- Conditions the study is for
- Eye Diseases
- What is being tested?
- WiSLO and Volk Pictor Plus™
- Type of treatment
- Medical device
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to 22 Apr 2026
- Phase
- Observational
- 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 30 days and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients eligible for this research study may have eye conditions requiring clinical evaluation. Participants will be recruited from the patient population of Duke Eye Center. Healthy adult volunteers will be recruited from the patient population of Duke Eye Center, visitors attending clinical visits with Duke Eye Center patients, Duke Employees and Duke Students. No employees or students will be enrolled if under the direct supervision of the PI.
Who may be able to join
- Adults (≥18 years) that may or may not have eye pathology
- Infant/child undergoing clinically-indicated examination that may or may not have eye pathology. NOTE: We will not enroll inpatient pre-term infants or neonates. The youngest age at enrollment will be 30 days adjusted age using the NICH NRN Web-based Adjusted Age Calculator.
- Adults and infant/child with or without prior pupil dilation for clinical eye care visit
- Adult participant is able and willing to consent to study participation
- Parent/Legal Guardian is able and willing to consent to study participation for the minor
- Pediatric participant >12 years is able and willing to assent to study participation
Who cannot join
- Participant or Parent/Legal Guardian unwilling or unable to provide consent
- Participant has a health or eye condition that would preclude eye examination or retinal imaging (e.g. evidence of inflammation or infection of ocular surface or eyelids, or corneal opacity or cataract)
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Eye Center
Durham, North Carolina, 27710
About this study
The goal of this observational study is to test the use of a novel Widefield Confocal Scanning Laser Ophthalmoscope (WiSLO) Optimized for Pediatric and Neonatal Imaging in pediatric and adult subjects who are undergoing clinical evaluation for eye disease or are healthy adult volunteers.
The main questions to answer are:
Read more
- Whether WiSLO will be more comfortable and satisfactory in experience for the patient and operator than commercial alternatives.
- If the quality of WiSLO near infrared images will be comparable to color fundus camera imaging across population of different ages and fundus pigmentation.
Participants will have the following research procedures:
- Imaging of both eyes with a research noncontact WiSLO
- Imaging of both eyes with a commercially available non-contact hand held fundus camera (Volk Pictor Plus)
- Likert scales for adults
- Pediatric Likert scales for children
- CRIES scales for infants.
Read the detailed description
The Widefield Confocal Scanning Laser Ophthalmoscope (WiSLO) Optimized for Pediatric and Neonatal Imaging study brings together a cross-disciplinary team of biomedical engineers and ophthalmologists to obtain feedback about and evaluate image quality of a handheld scanning laser ophthalmoscope (SLO) device designed and developed at Duke Biomedical Engineering under this grant specifically for portable pediatric and neonatal imaging applications which are not accessible by these populations. The expected outcome of the grant work is a validated design for a cost-scalable, dual-mode, widefield SLO (WiSLO) that produces NIR images comparable to existing color fundus cameras. The goal of this human subjects research is to gather initial supporting clinical data. Positive results from this initial study will motivate future technological refinement and clinical validation, ultimately leading to the commercialization of a technology that will greatly improve the standard of care in pediatric retinal imaging.
The investigators will recruit up to 42 participants into this study. This study will include enrollment of both pediatric and adult subjects who are undergoing clinical evaluation for eye disease or are healthy adult volunteers. Adult patients from Duke Eye Center Clinic with retinal findings will include for example, diabetic retinopathy, macular lesions, peripheral retinal lesions; Pediatric patients will have retinal findings including, for example: ROP, Coats disease, retinoschisis, familial exudative vitreoretinopathy, retinal detachment, retinal hemorrhages, retinoblastoma, and other lesions, or may have a normal retinal exam.
Participants will have the following research procedures: imaging of both eyes with (1) a research noncontact WiSLO and with a commercially available non-contact hand held fundus camera (Volk Pictor Plus), pen light evaluation of pupil size, sterile single use lubricating tear drops may be used, and Likert scales for adults, pediatric Likert scales for children and CRIES scales for infants. The adult cohort will complete imaging and analysis prior to start of pediatric imaging. Milestones of acceptable comfort with WiSLO imaging must be met from the adult analysis prior to imaging in pediatric participants.
Descriptive statistics will be computed for all retinal imaging variables (medians, means, standard deviations and ranges for continuous variables, and frequencies and percentages for categorical and binary variables). The significance of difference between imaging devices by eye for continuous variables (e.g. field of view, extent of each respective feature [from overlay with conventional image as reference standard], time to image), categorical variables (e.g. quality ratings) and binary variables (e.g. visualized yes or no) will be assessed using paired statistical tests (t-test or Wilcoxon signed rank test or McNemar's test, respectively). Comfort milestone prior to pediatric use: At least 8 of 10 adult participants must rate WiSLO imaging of equal or better comfort, and at least 5 of the participants must rate WiSLO better than the commercial handheld fundus camera. Further, the variabilities of results in use of the WiSLO versus commercial imaging systems will be contrasted. The relationships between WiSLO image findings vs color photograph findings and fundus pigmentation, age and other biological variables will be assessed graphically with scatterplots. Corresponding correlations will be computed to probe any associations between these biological measures and imaging outcomes.
Risks: There are no additional risks to participants beyond what is normal for standard ocular visualization and photographic procedures. Pharmacological pupil dilation will not be performed for research purposes.
- Conditions
- Eye Diseases
- Being tested
- WiSLO, Volk Pictor Plus™
- Medical subject headings
- Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WiSLODevice
Also called Widefield scanning laser ophthalmoscope
Imaging with the research WiSLO device in non-contact mode (4 images from each eye)
Volk Pictor Plus™Device
Imaging with the commercial handheld fundus camera, Volk Pictor Plus™ (4 images from each eye)
| Study group | Role | What they receive |
|---|---|---|
| Adult (≥18 years) cohort | Adults that may or may not have eye pathology Receives: Device: WiSLO; Device: Volk Pictor Plus™ | |
| Minor cohort | Infant/child undergoing clinically-indicated examination that may or may not have eye pathology. We will not enroll inpatient pre-term infants or neonates. The youngest age at enrollment will be 30 days adjusted age using the NICH NRN Web-based Adjusted Age Calculator. Receives: Device: WiSLO; Device: Volk Pictor Plus™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of microanatomy as measured by WiSLO image reading
Presence (Yes/No) of retinal anatomy as measured from WiSLO and commercial OCT grading
Measured: Standard of care clinic visit - day 1
Presence of abnormal microanatomy as measured by WiSLO image reading
Combination of presence (Yes/No) and severity (e.g., mild, moderate, severe) of abnormal retinal structures as measured from WiSLO images and commercially available fundus images.
Measured: Standard of care clinic visit - day 1
Presence of microanatomy from retinal photo imaging
Presence (Yes/No) of retinal microanatomy from commercially available fundus imaging (Volk Pictor Plus™) and WiSLO images.
Measured: Standard of care clinic visit - day 1
Severity of abnormal microanatomy from retinal photo imaging
Combination of presence (Yes/No) and severity (e.g., mild, moderate, severe) of abnormal retinal structures from commercially available fundus imaging (Volk Pictor Plus™) and WiSLO images.
Measured: Standard of care clinic visit - day 1
Time of image capture from WiSLO and commercially available fundus imaging
Assessment of time of image capture from both WiSLO and commercially available fundus imaging.
Measured: Standard of care clinic visit - day 1
Patient comfort as measured by Likert Scales
Determining subjective patient comfort and satisfaction using age appropriate Likert Scales for adults and minors (Likert scores 1 - 5)
Measured: Standard of care clinic visit - day 1
Patient satisfaction as measured by Likert Scales
Determining subjective patient comfort and satisfaction using age appropriate Likert Scales for adults and minors (Likert scores 1 - 5)
Measured: Standard of care clinic visit - day 1
Patient comfort as measured by CRIES evaluation
Determining subjective patient comfort and satisfaction CRIES evaluation (crying 0-4; facial expression 0-2; heart rate beats per minute; change in respiratory support).
Measured: Standard of care clinic visit - day 1
Patient satisfaction as measured by CRIES evaluation
Determining subjective patient comfort and satisfaction CRIES evaluation (crying 0-4; facial expression 0-2; heart rate beats per minute; change in respiratory support).
Measured: Standard of care clinic visit - day 1
Operator comfort as measured by Likert Scales
Determining subjective operator comfort and satisfaction using Likert Scales (Likert scores 1-5)
Measured: Standard of care clinic visit - day 1
Operator satisfaction as measured by Likert Scales
Determining subjective operator comfort and satisfaction using Likert Scales (Likert scores 1-5)
Measured: Standard of care clinic visit - day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start1 Oct 2025
- Primary completion22 Apr 2026
- Study completion22 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye DiseasesStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Sponsor
- Investigators
- Cynthia A Toth, MD, Principal investigator, Duke University Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06177639
- Sponsor's protocol ID
- Pro00111358
- Other IDs
- R21EY033515
- Acronym
- WiSLO
- Status last verified
- Sep 2026
- First submitted
- 11 Dec 2023
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: We are committed to prompt publication of research results as the optimal means for scientific advancement as well as career advancement for our students and trainees. All findings resulting from the proposed studies will be prepared for publication in peer-reviewed journals and posted on PubMed Central once accepted. Further, we are strong advocates of open-access publishing and are supportive of efforts by publishers and professional societies to develop technologies for on-line publishing of entire experimental datasets, although the technology for doing so in biomedical imaging research is still evolving. We have published such datasets using OSA's Interactive Science Publishing technology (http://midas.osa.org/midaspub/item/view/1123) and as supplementary data in OSA journals (https://www.osapublishing.org/submit/style/multimedia.cfm). We plan to either publish datasets from this study or make the datasets available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Widefield Confocal Scanning Laser Ophthalmoscope Optimized for Pediatric and Neonatal Imaging
- ClinicalTrials.gov ID
- NCT06177639
- Acronym / sponsor ID
- WiSLO / Pro00111358
- Conditions
- Eye Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 22 Apr 2026 (actual)
- Study completion
- 22 Apr 2026 (actual)
- First posted
- 20 Dec 2023 (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.
The goal of this observational study is to test the use of a novel Widefield Confocal Scanning Laser Ophthalmoscope (WiSLO) Optimized for Pediatric and Neonatal Imaging in pediatric and adult subjects who are undergoing clinical evaluation for eye disease or are healthy adult volunteers.
The main questions to answer are:
- Whether WiSLO will be more comfortable and satisfactory in experience for the patient and operator than commercial alternatives.
- If the quality of WiSLO near infrared images will be comparable to color fundus camera imaging across population of different ages and fundus pigmentation.
Participants will have the following research procedures:
- Imaging of both eyes with a research noncontact WiSLO
- Imaging of both eyes with a commercially available non-contact hand held fundus camera (Volk Pictor Plus)
- Likert scales for adults
- Pediatric Likert scales for children
- CRIES scales for infants.
Detailed description
The Widefield Confocal Scanning Laser Ophthalmoscope (WiSLO) Optimized for Pediatric and Neonatal Imaging study brings together a cross-disciplinary team of biomedical engineers and ophthalmologists to obtain feedback about and evaluate image quality of a handheld scanning laser ophthalmoscope (SLO) device designed and developed at Duke Biomedical Engineering under this grant specifically for portable pediatric and neonatal imaging applications which are not accessible by these populations. The expected outcome of the grant work is a validated design for a cost-scalable, dual-mode, widefield SLO (WiSLO) that produces NIR images comparable to existing color fundus cameras. The goal of this human subjects research is to gather initial supporting clinical data. Positive results from this initial study will motivate future technological refinement and clinical validation, ultimately leading to the commercialization of a technology that will greatly improve the standard of care in pediatric retinal imaging.
The investigators will recruit up to 42 participants into this study. This study will include enrollment of both pediatric and adult subjects who are undergoing clinical evaluation for eye disease or are healthy adult volunteers. Adult patients from Duke Eye Center Clinic with retinal findings will include for example, diabetic retinopathy, macular lesions, peripheral retinal lesions; Pediatric patients will have retinal findings including, for example: ROP, Coats disease, retinoschisis, familial exudative vitreoretinopathy, retinal detachment, retinal hemorrhages, retinoblastoma, and other lesions, or may have a normal retinal exam.
Participants will have the following research procedures: imaging of both eyes with (1) a research noncontact WiSLO and with a commercially available non-contact hand held fundus camera (Volk Pictor Plus), pen light evaluation of pupil size, sterile single use lubricating tear drops may be used, and Likert scales for adults, pediatric Likert scales for children and CRIES scales for infants. The adult cohort will complete imaging and analysis prior to start of pediatric imaging. Milestones of acceptable comfort with WiSLO imaging must be met from the adult analysis prior to imaging in pediatric participants.
Descriptive statistics will be computed for all retinal imaging variables (medians, means, standard deviations and ranges for continuous variables, and frequencies and percentages for categorical and binary variables). The significance of difference between imaging devices by eye for continuous variables (e.g. field of view, extent of each respective feature [from overlay with conventional image as reference standard], time to image), categorical variables (e.g. quality ratings) and binary variables (e.g. visualized yes or no) will be assessed using paired statistical tests (t-test or Wilcoxon signed rank test or McNemar's test, respectively). Comfort milestone prior to pediatric use: At least 8 of 10 adult participants must rate WiSLO imaging of equal or better comfort, and at least 5 of the participants must rate WiSLO better than the commercial handheld fundus camera. Further, the variabilities of results in use of the WiSLO versus commercial imaging systems will be contrasted. The relationships between WiSLO image findings vs color photograph findings and fundus pigmentation, age and other biological variables will be assessed graphically with scatterplots. Corresponding correlations will be computed to probe any associations between these biological measures and imaging outcomes.
Risks: There are no additional risks to participants beyond what is normal for standard ocular visualization and photographic procedures. Pharmacological pupil dilation will not be performed for research purposes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adult (≥18 years) cohort | – | Device: WiSLO, Device: Volk Pictor Plus™Adults that may or may not have eye pathology |
| Minor cohort | – | Device: WiSLO, Device: Volk Pictor Plus™Infant/child undergoing clinically-indicated examination that may or may not have eye pathology. We will not enroll inpatient pre-term infants or neonates. The youngest age at enrollment will be 30 days adjusted age using the NICH NRN Web-based Adjusted Age Calculator. |
Who may qualify
- Ages
- 30 days and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients eligible for this research study may have eye conditions requiring clinical evaluation. Participants will be recruited from the patient population of Duke Eye Center. Healthy adult volunteers will be recruited from the patient population of Duke Eye Center, visitors attending clinical visits with Duke Eye Center patients, Duke Employees and Duke Students. No employees or students will be enrolled if under the direct supervision of the PI.
Key inclusion criteria (6 listed)
- Adults (≥18 years) that may or may not have eye pathology
- Infant/child undergoing clinically-indicated examination that may or may not have eye pathology. NOTE: We will not enroll inpatient pre-term infants or neonates. The youngest age at enrollment will be 30 days adjusted age using the NICH NRN Web-based Adjusted Age Calculator.
- Adults and infant/child with or without prior pupil dilation for clinical eye care visit
- Adult participant is able and willing to consent to study participation
- Parent/Legal Guardian is able and willing to consent to study participation for the minor
Key exclusion criteria (2 listed)
- Participant or Parent/Legal Guardian unwilling or unable to provide consent
- Participant has a health or eye condition that would preclude eye examination or retinal imaging (e.g. evidence of inflammation or infection of ocular surface or eyelids, or corneal opacity or cataract)
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 |
|---|---|---|
| WiSLOAlso: Widefield scanning laser ophthalmoscopeImaging with the research WiSLO device in non-contact mode (4 images from each eye) | Device | Adult (≥18 years) cohort, Minor cohort |
| Volk Pictor Plus™Imaging with the commercial handheld fundus camera, Volk Pictor Plus™ (4 images from each eye) | Device | Adult (≥18 years) cohort, Minor cohort |
Primary outcome
Presence of microanatomy as measured by WiSLO image reading
Time frame: Standard of care clinic visit - day 1
Presence (Yes/No) of retinal anatomy as measured from WiSLO and commercial OCT grading
Presence of abnormal microanatomy as measured by WiSLO image reading
Time frame: Standard of care clinic visit - day 1
Combination of presence (Yes/No) and severity (e.g., mild, moderate, severe) of abnormal retinal structures as measured from WiSLO images and commercially available fundus images.
Presence of microanatomy from retinal photo imaging
Time frame: Standard of care clinic visit - day 1
Presence (Yes/No) of retinal microanatomy from commercially available fundus imaging (Volk Pictor Plus™) and WiSLO images.
Severity of abnormal microanatomy from retinal photo imaging
Time frame: Standard of care clinic visit - day 1
Combination of presence (Yes/No) and severity (e.g., mild, moderate, severe) of abnormal retinal structures from commercially available fundus imaging (Volk Pictor Plus™) and WiSLO images.
Time of image capture from WiSLO and commercially available fundus imaging
Time frame: Standard of care clinic visit - day 1
Assessment of time of image capture from both WiSLO and commercially available fundus imaging.
Patient comfort as measured by Likert Scales
Time frame: Standard of care clinic visit - day 1
Determining subjective patient comfort and satisfaction using age appropriate Likert Scales for adults and minors (Likert scores 1 - 5)
Patient satisfaction as measured by Likert Scales
Time frame: Standard of care clinic visit - day 1
Determining subjective patient comfort and satisfaction using age appropriate Likert Scales for adults and minors (Likert scores 1 - 5)
Patient comfort as measured by CRIES evaluation
Time frame: Standard of care clinic visit - day 1
Determining subjective patient comfort and satisfaction CRIES evaluation (crying 0-4; facial expression 0-2; heart rate beats per minute; change in respiratory support).
Patient satisfaction as measured by CRIES evaluation
Time frame: Standard of care clinic visit - day 1
Determining subjective patient comfort and satisfaction CRIES evaluation (crying 0-4; facial expression 0-2; heart rate beats per minute; change in respiratory support).
Operator comfort as measured by Likert Scales
Time frame: Standard of care clinic visit - day 1
Determining subjective operator comfort and satisfaction using Likert Scales (Likert scores 1-5)
Operator satisfaction as measured by Likert Scales
Time frame: Standard of care clinic visit - day 1
Determining subjective operator comfort and satisfaction using Likert Scales (Likert scores 1-5)
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 3 Sep 2026.
- Individual participant dataSharing planned: Yes. We are committed to prompt publication of research results as the optimal means for scientific advancement as well as career advancement for our students and trainees. All findings resulting from the proposed studies will be prepared for publication in peer-reviewed journals and posted on PubMed Central once accepted. Further, we are strong advocates of open-access publishing and are supportive of efforts by publishers and professional societies to develop technologies for on-line publishing of entire experimental datasets, although the technology for doing so in biomedical imaging research is still evolving. We have published such datasets using OSA's Interactive Science Publishing technology (http://midas.osa.org/midaspub/item/view/1123) and as supplementary data in OSA journals (https://www.osapublishing.org/submit/style/multimedia.cfm). We plan to either publish datasets from this study or make the datasets available upon request.
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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.
Cynthia A Toth, MD principal investigator
Duke University Eye Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eye Diseases, run by Duke University 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 6 inclusion and 2 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 3 Sep 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?
Presence of microanatomy as measured by WiSLO image reading (time frame: Standard of care clinic visit - day 1). The study lists 11 primary outcomes in all. 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 3 Sep 2026.