Observational Study of CXL in Keratoconus and Pain

This observational study is looking at how corneal crosslinking (CXL) treatment for keratoconus affects pain. Researchers want to understand if changes in pain can be measured in the brain using fMRI (functional magnetic resonance imaging) and in the eye's nerves using IVCM (in vivo confocal microscopy). They are also interested in whether these changes can be predicted. The study aims to see if CXL causes acute pain by activating certain nerves and if long-term pain is linked to changes in brain pathways and nerve regrowth. You might be able to join if you are between 8 and 35 years old, have keratoconus and are seeking CXL treatment, or if you are in the same age range without keratoconus. Success for this study means being able to identify and measure these changes in pain pathways and corneal nerves. The current recruitment status is unclear.

Study design
This is an observational study planning to enroll 60 participants, divided into a CXL group and a control group.
What's involved
Participants will need to be able to lie still for an MRI session lasting 60 minutes.
Compensation
Not stated in the trial record.
Follow-up
Neural activity related to pain and corneal nerve morphology will be measured at 1 year.

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NCT04439552

fMRI and IVCM Cornea Microscopy of CXL in Keratoconus

Recruiting
Not specifiedAges 8–35Observational
Boston Children's Hospital
~60 participants
Updated 2025-12-19 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Neural activity related to pain.
Measured over 1 year
+1 more outcome measured
Pain, Postoperative
Pain, Chronic
Pain, Acute
Surgical Injury
Surgical Wound
Cornea Injury
Cornea
Keratoconus
1 sites across 1 states
Massachusetts1
  • Eric A Moulton, OD PhD · PRINCIPAL_INVESTIGATOR · Boston Children's Hospital

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Eligibility criteria

Inclusion

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)
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

Claustrophobic
Weight \> 285 lbs (weight limit of the MRI table)
Significant medical history, including:
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
  • Neural activity related to pain.1 year

    Pain-related brain activation measured with fMRI.

  • Corneal nerve morphology.1 year

    Afferent nerve fiber morphology measured with IVCM.