fMRI and IVCM Cornea Microscopy of CXL in Keratoconus

Sponsor

Boston Children's Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04439552

Collaborator

(none)

Enrollment

Location

49.9

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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 (IVCM).

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative Pain, Chronic Pain, Acute Surgical Injury Surgical Wound Cornea Injury Cornea Keratoconus

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 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 Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 4, 2021

Anticipated Primary Completion Date :

Aug 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
CXL group Patients who are about to undergo a corneal cross-linking (CXL) surgery to treat keratoconus.
Control group Healthy volunteers age and sex matched to the CXL group.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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