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Search / Trial NCT04439552

fMRI and IVCM Cornea Microscopy of CXL in Keratoconus

Launched by BOSTON CHILDREN'S HOSPITAL · Jun 17, 2020

Trial Information

Current as of July 25, 2025

Recruiting

Keywords

F Mri Corneal Microscopy Ivcm Neuroimaging

ClinConnect Summary

This clinical trial is studying how pain pathways in the brain and the healing of nerve fibers in the eye respond after a treatment called corneal crosslinking (CXL) in patients with keratoconus, a condition that affects the shape of the cornea (the clear front part of the eye). Researchers will use advanced imaging techniques, including fMRI (a type of brain scan) and In Vivo Confocal Microscopy (a special eye imaging method), to observe these changes. The trial is currently recruiting participants aged 8 to 35, including those with keratoconus who are planning to receive CXL treatment and a control group of individuals without keratoconus.

To participate, you should be able to lie still for about an hour during the MRI scan and be comfortable with English, potentially with help from a parent or guardian. Certain conditions, such as claustrophobia or significant medical issues, may prevent you from joining the study. If you decide to participate, you’ll help researchers understand more about how CXL affects pain and nerve healing, which could lead to better treatments for people with keratoconus.

Gender

ALL

Eligibility criteria

  • 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

About Boston Children's Hospital

Boston Children's Hospital is a leading pediatric healthcare institution renowned for its commitment to advancing child health through innovative research and exceptional clinical care. As a prominent clinical trial sponsor, the hospital leverages its extensive expertise in pediatric medicine to conduct rigorous and ethically sound research studies aimed at improving treatment options and outcomes for children. With a collaborative approach that integrates cutting-edge technology and multidisciplinary teams, Boston Children's Hospital is dedicated to translating scientific discoveries into practical applications that enhance the well-being of young patients and their families.

Locations

Boston, Massachusetts, United States

Patients applied

0 patients applied

Trial Officials

Eric A Moulton, OD PhD

Principal Investigator

Boston Children's Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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