A Multicentre, Prospective, Longitudinal, Observational Natural History Study to Evaluate Disease Progression in Subjects with Usher Syndrome type 1B (USH1B)

A Multicentre, Prospective, Longitudinal, Observational Natural History Study to Evaluate Disease Progression in Subjects with Usher Syndrome type 1B (USH1B) - Natural history of Usher syndrome type 1B

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON46147

Enrollment

Registered

2018-08-08

Start date

2018-12-12

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Usher syndrome type 1B

Interventions

None listed

Eligibility

Age

2 Years to 99 Years

Inclusion criteria

Inclusion criteria: Informed consent Diagnosed with USH1 Molecular diagnosis of USH1B due to MYO7A mutations (homozygotes or compound heterozygotes) Age >= 8 years Visual acuity >= 20/640 in at least one eye

Exclusion criteria

Exclusion criteria: Unable to communicate with suitable verbal/auditory and/or tactile sign language Participation in clinical study with investigational drug in past 6 months Pre-existing ocular conditions that would interfere with the interpretation of study endpoints (e.g. glaucoma, corneal or significant lenticular opacities, cystoid macular oedema, macular hole) in both eyes Complicating systemic diseases in which the disease itself, or the treatment for the disease, can alter ocular function Prior ocular surgery within 3 months

Design outcomes

Primary

Measure	Time frame
Visual acuity & visual field.	—

Secondary

Measure	Time frame
IOP ERG OCT Fundusphotographs VFQ-25	—

Countries

Netherlands

Outcome results