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NCT Number: NCT04439552

fMRI and IVCM Cornea Microscopy of CXL in Keratoconus

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).

Recruiting

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Neural activity related to pain.

    Time frame: 1 year

    Pain-related brain activation measured with fMRI.

  2. Corneal nerve morphology.

    Time frame: 1 year

    Afferent nerve fiber morphology measured with IVCM.

Study contacts

Contact information is provided by the study sponsor or research team.

Eric A Moulton, OD PhD

CONTACT

[email protected]

617-919-6827

Nicholas J Pondelis, BA

CONTACT

[email protected]

617-919-1895

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Official study title

Neuroplasticity of Pain Pathways and Corneal Afferent Regeneration Following Corneal Crosslinking (CXL) in Keratoconus

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jun 19, 2020
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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