Validation and Reliability of Iris Cameras in Mucopolysaccharidoses

NCT05354219 | Unknown DMC

• 1 other identifier: IRAS 315339
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mucopolysaccharidoses

Outcome Measures

Primary Outcomes (2)

• 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

  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

  2 months

Secondary Outcomes (1)

• Comparison of clinical grading to COM score obtained by image analysis

  1 month

Study Arms (2)

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

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

Interventions

Imaging OTHER

Imaging with 3 iris cameras

Control; MPS patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

MPS patients and healthy controls

You may qualify if:

• 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.

You may not qualify if:

• MPS II

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead
• Orchard Therapeutics: collaborator

Study Sites (1)

Manchester University NHS Foundation Trust

Manchester, M13 9WL, United Kingdom

RECRUITING

MeSH Terms

Conditions

Mucopolysaccharidoses

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lysosomal Storage Diseases; Mucinoses; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Central Study Contacts

Jane Ashworth, MD

CONTACT

0161 276 1234; jane.ashworth@mft.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: April 29, 2022
• Study Start: March 8, 2023
• Primary Completion: September 8, 2023
• Study Completion: September 8, 2023
• Last Updated: March 22, 2023

Record last verified: 2023-03

Locations

GB (1)