Validation and Reliability of Iris Cameras in Mucopolysaccharidoses

Sponsor

Manchester University NHS Foundation Trust (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05354219

Collaborator

Orchard Therapeutics (Industry)

Enrollment

Location

Anticipated Duration (Months)

19.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To assess the reliablity and validity of 2 new iris cameras in the assement of corneal opacification in mucopolysaccharidoses

Condition or Disease	Intervention/Treatment	Phase
Mucopolysaccharidoses	Other: Imaging

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

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Anticipated Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.	Other: Imaging Imaging with 3 iris cameras
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.	Other: Imaging Imaging with 3 iris cameras

Arm

Intervention/Treatment

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.

Other: Imaging

Imaging with 3 iris cameras

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.

Other: Imaging

Imaging with 3 iris cameras

Outcome Measures

Primary Outcome Measures

Comparison of reliability of images taken by two different operators using the two ne w iris cameras [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 [2 months]
Validity will be assessed by comparing the COM scores generated by the new iris cams to the previously validated iris camera

Secondary Outcome Measures

Comparison of clinical grading to COM score obtained by image analysis [1 month]
Compare clinical grading of corneal opacification on slit lamp by clinicians to corneal opacification measure generated by image analysis

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

Exclusion Criteria:

MPS II

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Manchester University NHS Foundation Trust	Manchester		United Kingdom	M13 9WL

Sponsors and Collaborators

Manchester University NHS Foundation Trust
Orchard Therapeutics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Manchester University NHS Foundation Trust

ClinicalTrials.gov Identifier:

NCT05354219

Other Study ID Numbers:

IRAS 315339

First Posted:

Apr 29, 2022

Last Update Posted:

Apr 29, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Mucopolysaccharidoses

Study Results

No Results Posted as of Apr 29, 2022