Research with human participants

Overview of medical research in the Netherlands

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

Published:
Last updated:

To evaluate the natural progression of disease over time in USH1B patients using visual field testing and best corrected visual acuity.

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Ethical review
Approved WMO
Status
Recruitment stopped
Health condition type
Eye disorders NEC
Study type
Observational non invasive

ID

NL-OMON46147

Source

ToetsingOnline

Brief title

Natural history of Usher syndrome type 1B

Condition

  • Eye disorders NEC

Synonym

Usher syndrome type 1B

Research involving

Human

Sponsors and support

Primary sponsor :
Oogziekenhuis Rotterdam
Source(s) of monetary or material Support :
EU

Intervention

Keyword :
Natural history, Usher syndrome type 1B, Vision

Outcome measures

Primary outcome

Visual acuity & visual field.

Secondary outcome

IOP

ERG

OCT

Fundusphotographs

VFQ-25

Background summary

This natural history study is being conducted to understand the progression of
disease in USH1B patients as measured by visual acuity and visual field testing
and a number of other vision-related assessments.

Study objective

To evaluate the natural progression of disease over time in USH1B patients
using visual field testing and best corrected visual acuity.

Study design

Multicenter, prospective, observational.

Study burden and risks

Electrodes for ERG measurements can cause superficial abrasions of the cornea
which usually heal spontaneously within one day. Other risks are minimal.
Subjects do not benefit from participation. Due to the extensive measurements,
participation can be somewhat exhausting; subjects are encouraged to indicate
when they need a break. Study related time: 3 times two days.

Public
Oogziekenhuis Rotterdam

Schiedamse Vest 180
Rotterdam 3011 BH
NL
Scientific
Oogziekenhuis Rotterdam

Schiedamse Vest 180
Rotterdam 3011 BH
NL

Listed location countries

Netherlands

Age

Adolescents (12-15 years)
Adolescents (16-17 years)
Adults (18-64 years)
Children (2-11 years)
Elderly (65 years and older)

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

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

Study type :
Observational non invasive
Masking :
Open (masking not used)
Control :
Uncontrolled
Primary purpose :
Other

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
10
Type :
Actual

Approved WMO
Date :
Application type :
First submission
Review commission :
METC Erasmus MC, Universitair Medisch Centrum Rotterdam (Rotterdam)

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
CCMO NL66164.078.18