PANDA-ASOCT: Paediatric Anterior Uveitis Detection With Automated Image Analysis Using ASOCT (PANDA)

September 4, 2026 updated by: Sheffield Children's NHS Foundation Trust

An Observational Longitudinal Cohort Study on the Clinical Application of Anterior Segment Ocular Coherence Tomography (AS-OCT) as an Imaging Tool in Detecting, Grading and Monitoring Non-infectious Anterior Uveitis, in Age 2 to 16 Years Old, in a Single Regional Multi-disciplinary Paediatric Uveitis Service, Comparing With the Standard Slit Lamp Examination, and Development of Deep Learning in Automated Analysis

Uveitis, an inflammation inside the eye. Although rare, it is an important auto-inflammatory eye condition that affect children and young people (CYP). If not identified and treated promptly, it can lead to permanent vision loss. Uveitis is estimated to affect around 4-5 in every 100,000 children, and up to 26% of those with childhood-onset disease may develop severe visual impairment. Because uveitis often causes no symptoms, even when it is advanced, it is sometimes described as a "silent blinding disease" Uveitis can occur on its own or together with other immune-related conditions. It is the most common non-joint (extra-articular) complication of Juvenile Idiopathic Arthritis (JIA), the most frequent childhood auto-inflammatory joint disorder, which affects about 5.6 per 100,000 children in the UK. National guidelines from the Royal Colleges recommend regular uveitis screening for all children and young people with JIA.

This study aims to assess whether a high-resolution, non-irradiating eye imaging system can accurately detect inflammatory cells inside the eye objectively. The scan is non-invasive, non-contact, painless, and well tolerated by children. It can take 50,000 images per second, allowing the front of the eye to be captured in seconds. These images will be analysed using validated automated algorithms to identify and measure signals from inflammatory cells objectively, without influence of human factor. The qualitative and quantitative information may help predict disease activity and monitor treatment response.

We aim to compare the imaging results with the current standard slit-lamp eye examination in 300 children and young people (600 eyes). Both the imaging operators and the senior clinical examiners will be not know what each other's findings. The primary aim is to determine how AS-OCT imaging system is in detecting uveitis in children and if the results is the same as the standard eye test. The measurement data will also support early-phase deep-learning development to create a cost-effective, automated tool for diagnosing, grading, and crucially monitoring uveitis over time, particularly during treatments that involve complex immunosuppressive medications.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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

Uveitis, an inflammation inside the eye, is a rare auto-inflammatory eye condition in children and young people (CYP). It is a potentially blinding disorder if left untreated. Uveitis is a preventable blindness in CYP, estimated 4-5 per 100,000 children developing it. Blindness was reported in 26% of childhood onset uveitis. Children with uveitis do not always have symptoms, even in the most severe end-stage, and often labelled as 'silent blinding disease'. Uveitis can occur in association with systemic auto-immune disorder and is the main extra-articular manifestation of juvenile idiopathic arthritis (JIA). JIA is the most common auto-inflammatory joints disease in children, affecting 5.6 per 100,000 children in the United Kingdom. Guidelines published by the Royal Colleges recommend uveitis screening for all CYP with JIA. This study aims to evaluate the clinical application of a high-resolution non-irradiating imaging system to detect inflammatory cells inside the eye. The camera is non-invasive, non-contact and well tolerated in children. It has a scan-speed of 50,000 images per second. The entire front of the eye can be scanned in 1.2 seconds. The images will be analysed using an appropriately calibrated automated algorithms to detect signals from inflammatory cells objectively. The qualitative and quantitative measurements can be used to predict disease and monitor treatment response. The imaging data will be compared with current standard eye examination in 300 children (600 eyes), masking both the scanner operators and the senior examiners in clinics. The primary objective is to assess sensitivity of the automated imaging system in detecting and predicting uveitis in children. The quantification data will contribute to early phase of deep learning in developing a cost-effective automated diagnostic tool in detecting, grading and most importantly monitoring of uveitis objectively during treatment(s) which often involve complex immunosuppressive agents.

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.
Observational

Enrollment (Estimated)

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.
300

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United Kingdom
    • South Yorkshire
      • Sheffield, South Yorkshire, United Kingdom, S10 2TH

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

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Paediatric patients at Sheffield Children's Hospital, who have been referred to the clinics for uveitis and JIA-uveitis.

Description

Inclusion Criteria:

  • Aged between 2 and 16 years
  • Attending uveitis and JIA-uveitis clinic at Sheffield Children's Hospital
  • Parents/carers give informed written consent and CYP give age-appropriate assent

Exclusion Criteria:

  • Unable to obtain parental/carer written consent
  • CYP does not want to be recruited

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Patients attending uveitis clinic
Patients attending uveitis screening clinic, or those attending Jeuvenile Ideopathic Arthritis Uveitis screening clinic.
Diagnostic test: Slit Lamp Examination
Standard of care slit lamp examination for Uveitis.
Diagnostic test: Anterior segment ocular coherence tomography (ASOCT)
ASOCT provides high-resolution cross-sectional imaging of the anterior chamber of the eye.

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
Index test (ASOCT) images
Time Frame: At time of enrolment visit
The ASOCT device will be used to image the eyes of the patient. Pseudo-anonymised cross-sectional scans will be analysed using application Image J (National Institutes of Health, United States).
At time of enrolment visit
Reference Test (slit lamp examination)
Time Frame: At time of enrolment visit.
The slit-lamp is the standard clinical examination with a bright light beam of 1x1mm, at high magnification by the ophthalmologists and screening optometrists. The number of visible cellular dots in the anterior chamber will be scored according to the international standard SUN criteria, as 0, ½+ (1-5 cells), 1+ (6-15 cells), 2+ (16-25 cells), 3+ (26-50 cells) and 4+ (> 50 cells).
At time of enrolment visit.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Demographic data
Time Frame: At time of enrolment visit.
Age, biological sex, ethnicity, co-morbidities, ocular history, systemic history, ocular diagnosis, visual acuity, intraocular pressure, current and previous treatments including topical and systemic medication.
At time of enrolment visit.
Iris colour
Time Frame: At time of enrolment visit.
Iris colour as matched to a reference sheet.
At time of enrolment visit.

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.
Sheffield Children's NHS Foundation Trust

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 (Estimated)

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.
September 1, 2026

Primary Completion (Estimated)

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.
February 1, 2027

Study Completion (Estimated)

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.
February 1, 2027

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).
September 4, 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.
September 4, 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.
September 10, 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.
September 10, 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.
September 4, 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.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • SCH-2925
  • 351221 (Other Identifier: IRAS Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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