C-Fiber Assays in the Cornea vs. Skin.
Eric A Moulton, David Borsook
https://pubmed.ncbi.nlm.nih.gov/31718074/Actively Recruiting
Led by Boston Children's Hospital · Updated on 2025-12-19
60
Participants Needed
1
Research Sites
17 weeks
Total Duration
Researchers are studying changes in nerve function and regeneration after corneal crosslinking CXL surgery in patients with keratoconus, a condition affecting the cornea. The study aims to understand how acute pain may develop into chronic pain after CXL by using brain imaging fMRI and detailed corneal nerve imaging in vivo confocal microscopy. They also want to see if biological and psychological factors can predict these pain outcomes. The study compares two groups patients scheduled for CXL surgery and healthy volunteers matched by age and sex. Participants will undergo assessments before and after the procedure to observe nerve changes and brain activity related to pain. This observational study does not involve any treatment assignment but monitors natural changes following CXL. Participants will be involved in MRI scanning sessions lasting about 60 minutes to measure brain activity and corneal nerve structure. Researchers will use these results to evaluate neural activity related to pain and corneal nerve morphology at one year. The study requires the ability to remain still during MRI and includes both patients with keratoconus and healthy controls, with total participation lasting up to one year.
CONDITIONS
fMRI and IVCM Cornea Microscopy of CXL in Keratoconus
E
Eric A Moulton, OD PhD
N
Nicholas J Pondelis, BA
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Boston Children's Hospital
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants undergo functional neuroimaging (fMRI) and in vivo corneal microscopy (IVCM) to assess neural activity and corneal nerve morphology related to pain.
1 visit (in-person)
Duration - 1 year
Participants are observed over 1 year to evaluate changes in neural activity and corneal nerve morphology associated with post-operative pain and corneal afferent regeneration.
Periodic assessments over 1 year
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Lead Sponsor