Evaluating pain pathways and nerve regeneration in keratoconus patients after corneal crosslinking

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the neuroplasticity of pain pathways and the regeneration of corneal afferent nerves in patients with keratoconus who undergo corneal crosslinking (CXL). Using functional MRI and in vivo corneal microscopy, the study will quantify structural and functional changes associated with acute and chronic pain following CXL. It will also explore the influence of biological and psychological factors on pain outcomes. The central hypothesis is that CXL induces acute pain through trigeminal afferent activation, with chronic pain linked to neuroplastic changes and nerve regeneration.

Why it matters

Who can join: the full rules

Inclusion Criteria:

CXL Group

* Age 8-35 years
* Clinical diagnosis of keratoconus and seeking CXL treatment
* English speaking ability sufficient to comprehend consent with parental assistance
* MRI compatible
* Ability to lie still for an MRI session (60 minutes)

Control Group

* Age 8-35 years
* No diagnosis of keratoconus
* English speaking ability sufficient to comprehend consent with parental assistance
* MRI compatible
* Ability to lie still for an MRI session (60 minutes)

Exclusion Criteria (Both Groups):

* Claustrophobic
* Weight \> 285 lbs (weight limit of the MRI table)
* Significant medical history, including:

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

* Magnetic implants or metal-containing tattoos on their chest or above
* Pregnancy
* History of contact lens wear
* Any allergic response to a numbing eyedrop in the past

Where it's running

• Boston Children's Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Eric A Moulton, OD PhD — Boston Children's Hospital
• Study coordinator: Eric A Moulton, OD PhD
• Email: eric.moulton@childrens.harvard.edu
• Phone: 617-919-6827

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.