Status:
RECRUITING
fMRI and IVCM Cornea Microscopy of CXL in Keratoconus
Lead Sponsor:
Boston Children's Hospital
Conditions:
Pain, Postoperative
Pain, Chronic
Eligibility:
All Genders
8-35 years
Brief Summary
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 (...
Detailed Description
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 structur...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 4 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04439552
Start Date
October 4 2021
End Date
December 1 2027
Last Update
December 19 2025
Active Locations (1)
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1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115