An observational study in Pain, Postoperative, Pain, Chronic and Pain, Acute, sponsored by Boston Children's Hospital. Recruiting at 1 site in United States. Open to participants aged 8 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-19.
Sponsored by Boston Children's Hospital · Observational
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).
Our long-term goal is to evaluate the transition from acute to chronic pain that sometimes occurs following CXL in keratoconus patients. This study will determine whether these changes can be structurally and functionally quantified using functional neuroimaging and in vivo corneal microscopy (IVCM), and whether they can be predicted based on predisposing biological and psychological factors. Our central hypothesis is that CXL produces acute pain through activation of trigeminal afferents, and that post-operative chronic pain outcomes are related to neuroplastic changes in trigeminal circuitry, corneal afferent regeneration, and psychological factors.
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.
CXL Group
Control Group
Exclusion Criteria (Both Groups):
Current DSM-IV-TR axis I psychiatric disorders. Chronic pain Significant head injury Seizures Brain tumor Cerebrovascular accident Neurological disease aside from migraine HIV-AIDs Prescription medication strongly implicated in causing dry eyes
Patients who are about to undergo a corneal cross-linking (CXL) surgery to treat keratoconus.
Healthy volunteers age and sex matched to the CXL group.
Neural activity related to pain.
Pain-related brain activation measured with fMRI.
Time frame: 1 year
Corneal nerve morphology.
Afferent nerve fiber morphology measured with IVCM.
Time frame: 1 year
Plan to share: Yes — All IPD that underlie results in a publication
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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