fMRI and IVCM Cornea Microscopy of CXL in Keratoconus

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04439552

Enrollment

Registered

2020-06-19

Start date

2021-10-04

Completion date

2027-12-31

Last updated

2025-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

fMRI, Corneal Microscopy, IVCM, Neuroimaging

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).

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

8 Years to 35 Years

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 * 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

Design outcomes

Primary

Measure	Time frame	Description
Corneal nerve morphology.	1 year	Afferent nerve fiber morphology measured with IVCM.
Neural activity related to pain.	1 year	Pain-related brain activation measured with fMRI.

Countries

United States

Contacts

Primary ContactEric A Moulton, OD PhD

eric.moulton@childrens.harvard.edu617-919-6827

Backup ContactNicholas J Pondelis, BA

nicholas.pondelis@childrens.harvard.edu617-919-1895

Outcome results