We purpose to determine whether the international normative values are applicable in our center in 10 healthy participants. Furthermore, CCM will be introduced as additional diagnostic tool in patients with (possible) SFN.
ID
Source
Brief title
Condition
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Corneal nerve fiber density (CNFD), branch density (CNBD), fiber length (CNFL),
and the tortuosity coefficient (CNFT) will be determined in all participants.
Secondary outcome
-
Background summary
According the international criteria, the diagnosis small fiber neuropathy
(SFN) is based on clinical symptoms in combination with a reduced
intraepidermal nerve fiber density (IENFD) in skin biopsy and/or abnormal
temperature threshold testing (TTT). The sensitivity of skin biopsy is moderate
to good, although IENFD is normal in about 12% of patients with SFN complaints.
Furthermore, TTT is a widely available diagnostic tool, but this test lacks
specificity. Corneal confocal microscopy (CCM) had been described and is used
in clinical practice as an objective, non-invasive diagnostic tool to detect
small nerve fiber damage in patients with diabetes mellitus. This study
examines the applicability of CCM in patients with possible SFN, and the value
of CCM as an additional diagnostic tool in SFN.
Study objective
We purpose to determine whether the international normative values are
applicable in our center in 10 healthy participants. Furthermore, CCM will be
introduced as additional diagnostic tool in patients with (possible) SFN.
Study design
The study has a cross-sectional design.
Study burden and risks
The ophthalmologic examination has no special hazard for the condition of the
participants.
There is a very small risk of corneal erosion. This is a superficial wound of
the cornea. After the examination, normal vision is expected. It is not
recommended to wear contact lenses on the research day, both before and after
the examination.
In total, completing the questionnaire and the entire ophthalmological
examination cost about 25 minutes.
Oxfordlaan 10 -
Maastricht 6229 HX
NL
Oxfordlaan 10 -
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
Healthy subjects (n<=20)
a. Male and female subjects of 18 years or older
b. One or less positive answers on the SFN-SIQ
c. Written informed consent;Patients (n<=200):
Those who are referred to our center for the analysis of possible small fiber neuropathy are eligible for participation in this study.
Exclusion criteria
Healthy subjects (n=20)
- Sensory symptoms in hands or feet or known with mono-/polyneuropathy.
- Known illnesses that can cause neuropathy, like diabetes mellitus, renal failure, alcohol abuse, rheumatoid arthritis, SLE, sarcoidosis, and thyroid dysfunction.
- History of diseases of the eye such as dry eyes, atopic keratoconjunctivitis, epithelial membrane basement dystrophies, cystic corneal disorders, which all affect corneal innervation.
- Patients with chronic glycemic exposure since this is a strong risk factor for corneal subbasal nerve loss.
- Use of medication (also in the past) known to possibly cause polyneuropathy.;Patients (n=200)
- History of diseases of the eye (such as mentioned above);Participants are excluded from this study when they do not want to be informed about defects or accidental findings which could be found during the pre-screening of the ophthalmologist.
Design
Recruitment
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 | NL53973.068.15 |