fMRI and IVCM Cornea Microscopy of CXL in Keratoconus

Boston Children's Hospital60 enrolled

Overview

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).

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Pain, Postoperative Pain, Chronic Pain, Acute Surgical Injury Surgical Wound Cornea Injury Cornea Keratoconus

Eligibility

Sex: ALLMin age: 8 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Boston Children's Hospital

Boston, Massachusetts, United States

RECRUITING

Outcomes

Primary Outcomes

Neural activity related to pain.

Pain-related brain activation measured with fMRI.

Time frame: 1 year

Corneal nerve morphology.

Afferent nerve fiber morphology measured with IVCM.

Time frame: 1 year

Central Contacts

Eric A Moulton, OD PhD

CONTACT

617-919-6827 eric.moulton@childrens.harvard.edu

Nicholas J Pondelis, BA

CONTACT

617-919-1895 nicholas.pondelis@childrens.harvard.edu

Data from ClinicalTrials.gov

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