MucopolysaccharidosesNCT05354219
Validation and Reliability of Iris Cameras in Mucopolysaccharidoses
An observational study of Mucopolysaccharidoses, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
To assess the reliablity and validity of 2 new iris cameras in the assement of corneal opacification in mucopolysaccharidoses Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Mucopolysaccharidoses
- What is being tested?
- Imaging
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Mar 2023to 8 Sep 2023
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: MPS patients and healthy controls
Who may be able to join
- Any patient aged 0-100 with MPS type I, type III, type IV and type VI. Type VII MPS patients may also be eligible.
- For the control group -
- Participants of any age currently being followed at MREH that have an eye condition unrelated to the cornea as established by clinical examination.
Who cannot join
- MPS II
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Manchester University NHS Foundation Trust
Manchester, M13 9WL
Zaria Ali, MBChB, 01612765560, Zaria.ali@mft.nhs.uk
Fiona Crawford, PhD, mreh.research@mft.nhs.uk
About this study
Official title: Validation and Reliability of Iris Recognition and Manual InfraRed Cameras Using Bespoke Image Analysis Software for the Quantification of Corneal Opacification in Mucopolysaccharidoses
To assess the reliablity and validity of 2 new iris cameras in the assement of corneal opacification in mucopolysaccharidoses
Read the detailed description
The mucopolysaccharidoses (MPS) are a group of disorders resulting from accumulation of glycosaminoglycans within various tissues including the eye. This can result in visual loss from corneal opacification. The assessment of corneal opacification is extremely subjective and based on a clinician grading this during slit lamp examination. There can be a significant variability and can prove problematic particularly in clinical trials assessing if corneal opacification is affected by potential new treatments.
The use of imaging could facilitate objective measurement of corneal clouding. A previous study using an iris camera and image analysis to provide a corneal opacification measure score (COM score) demonstrated that it can be used in children with MPS, however it still had limitations- as the system is fully automated, if certain conditions are not met an image is not captured. This can be an issue in younger children who may not be cooperative, and limited its use in younger patient populations.
It is anticipated that these limitations can be addressed by employing a newer iris camera (IriShield MK2120UL). The new camera's advantage is that it takes images monocularly, therefore only the eye under question needs to be aligned. We will also assess a new manual system (IRcamNew) which takes images whenever the shutter is manually pressed. This would be useful in children who cannot fixate with one eye, and can also be used when the child is examined under general anaesthetic which is commonly done in paediatric ophthalmology.
If proven to be comparable to the existing iris camera (IriscamOrig) in terms of validity and reliability, the added benefits of these new iris cameras can open its use in a wider range of patient populations - for instance, in paediatric clinical trials-, as well as allowing longitudinal tracking of corneal clouding from early childhood well into adulthood.
- Conditions
- Mucopolysaccharidoses
- Being tested
- Imaging
- Medical subject headings
- Mucopolysaccharidoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImagingOther
Imaging with 3 iris cameras
| Study group | Role | What they receive |
|---|---|---|
| MPS patients | Any patient aged 0-100 with MPS type I, type III, type IV and type VI. Type VII MPS patients may also be eligible. Receives: Other: Imaging | |
| Control | For the control group -
Participants of any age currently being followed at MREH that have an eye condition unrelated to the cornea as established by clinical examination. Receives: Other: Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of reliability of images taken by two different operators using the two ne w iris cameras
Bland altman plots to compare reliability between images and COM scores obtained by 2 different operators
Measured: 2 months
Correlation of COM scores between two new iris cameras and IrisCamOrig
Validity will be assessed by comparing the COM scores generated by the new iris cams to the previously validated iris camera
Measured: 2 months
Secondary outcomes (1)
Comparison of clinical grading to COM score obtained by image analysis
Compare clinical grading of corneal opacification on slit lamp by clinicians to corneal opacification measure generated by image analysis
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start8 Mar 2023
- Primary completion8 Sep 2023 (estimated)
- Study completion8 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MucopolysaccharidosesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- Orchard Therapeutics
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05354219
- Sponsor's protocol ID
- IRAS 315339
- Status last verified
- Mar 2023
- First submitted
- 12 Apr 2022
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation and Reliability of Iris Recognition and Manual InfraRed Cameras Using Bespoke Image Analysis Software for the Quantification of Corneal Opacification in Mucopolysaccharidoses
- ClinicalTrials.gov ID
- NCT05354219
- Acronym / sponsor ID
- IRAS 315339
- Conditions
- Mucopolysaccharidoses
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Collaborators
- Orchard Therapeutics
- Study start
- 8 Mar 2023 (actual)
- Primary completion
- 8 Sep 2023 (estimated)
- Study completion
- 8 Sep 2023 (estimated)
- First posted
- 29 Apr 2022 (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.
To assess the reliablity and validity of 2 new iris cameras in the assement of corneal opacification in mucopolysaccharidoses
Detailed description
The mucopolysaccharidoses (MPS) are a group of disorders resulting from accumulation of glycosaminoglycans within various tissues including the eye. This can result in visual loss from corneal opacification. The assessment of corneal opacification is extremely subjective and based on a clinician grading this during slit lamp examination. There can be a significant variability and can prove problematic particularly in clinical trials assessing if corneal opacification is affected by potential new treatments.
The use of imaging could facilitate objective measurement of corneal clouding. A previous study using an iris camera and image analysis to provide a corneal opacification measure score (COM score) demonstrated that it can be used in children with MPS, however it still had limitations- as the system is fully automated, if certain conditions are not met an image is not captured. This can be an issue in younger children who may not be cooperative, and limited its use in younger patient populations.
It is anticipated that these limitations can be addressed by employing a newer iris camera (IriShield MK2120UL). The new camera's advantage is that it takes images monocularly, therefore only the eye under question needs to be aligned. We will also assess a new manual system (IRcamNew) which takes images whenever the shutter is manually pressed. This would be useful in children who cannot fixate with one eye, and can also be used when the child is examined under general anaesthetic which is commonly done in paediatric ophthalmology.
If proven to be comparable to the existing iris camera (IriscamOrig) in terms of validity and reliability, the added benefits of these new iris cameras can open its use in a wider range of patient populations - for instance, in paediatric clinical trials-, as well as allowing longitudinal tracking of corneal clouding from early childhood well into adulthood.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MPS patients | – | Other: ImagingAny patient aged 0-100 with MPS type I, type III, type IV and type VI. Type VII MPS patients may also be eligible. |
| Control | – | Other: ImagingFor the control group - Participants of any age currently being followed at MREH that have an eye condition unrelated to the cornea as established by clinical examination. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- MPS patients and healthy controls
Key inclusion criteria (3 listed)
- Any patient aged 0-100 with MPS type I, type III, type IV and type VI. Type VII MPS patients may also be eligible.
- For the control group -
- Participants of any age currently being followed at MREH that have an eye condition unrelated to the cornea as established by clinical examination.
Key exclusion criteria (1 listed)
- MPS II
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 |
|---|---|---|
| ImagingImaging with 3 iris cameras | Other | Control, MPS patients |
Primary outcome
Comparison of reliability of images taken by two different operators using the two ne w iris cameras
Time frame: 2 months
Bland altman plots to compare reliability between images and COM scores obtained by 2 different operators
Correlation of COM scores between two new iris cameras and IrisCamOrig
Time frame: 2 months
Validity will be assessed by comparing the COM scores generated by the new iris cams to the previously validated iris camera
1 secondary outcome
Comparison of clinical grading to COM score obtained by image analysis
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Individual participant dataSharing planned: Undecided
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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.
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 Mucopolysaccharidoses, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 22 Mar 2023. 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 Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jane Ashworth, MD (0161 276 1234, jane.ashworth@mft.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of reliability of images taken by two different operators using the two ne w iris cameras (time frame: 2 months). The study lists 2 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 22 Mar 2023.