fMRI and IVCM Cornea Microscopy of CXL in Keratoconus

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8-35
SponsorBoston Children's Hospital

About this trial

Evaluation of neuroplasticity of pain pathways and corneal afferent nerve regeneration following corneal crosslinking (CXL) in keratoconus patients using fMRI and corneal In Vivo Confocal Microscopy (IVCM).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 8-35 years

Clinical diagnosis of keratoconus and seeking CXL treatment

English speaking ability sufficient to comprehend consent with parental assistance

MRI compatible

Disqualifiers

Claustrophobic

Weight > 285 lbs (weight limit of the MRI table)

Magnetic implants or metal-containing tattoos on their chest or above

Pregnancy

Trial population

The population under study are patients with keratoconus who are undergoing a corneal cross-linking (CXL) procedure. Keratoconus is an eye condition where the cornea progressively develops abnormally into a cone shape, which can lead to distorted vision and irreversible vision loss The CXL procedure is designed to restore and maintain the shape of the cornea to avoid these complications.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

60 Participants
are grouped into 2 trial groups
Group A: CXL group
Group B: Control group

Trial outcomes

Primary outcomes

1

Neural activity related to pain.

Pain-related brain activation measured with fMRI.

Time frame
1 year
2

Corneal nerve morphology.

Afferent nerve fiber morphology measured with IVCM.

Time frame
1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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