Evaluating pain pathways and nerve regeneration in keratoconus patients after corneal crosslinking
Neuroplasticity of Pain Pathways and Corneal Afferent Regeneration Following Corneal Crosslinking (CXL) in Keratoconus
Boston Children's Hospital · NCT04439552
This study is testing how corneal crosslinking affects pain and nerve healing in people with keratoconus to see how their pain changes over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 8 Years to 35 Years |
| Sex | All |
| Sponsor | Boston Children's Hospital (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04439552 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the neuroplasticity of pain pathways and the regeneration of corneal afferent nerves in patients with keratoconus who undergo corneal crosslinking (CXL). Using functional MRI and in vivo corneal microscopy, the study will quantify structural and functional changes associated with acute and chronic pain following CXL. It will also explore the influence of biological and psychological factors on pain outcomes. The central hypothesis is that CXL induces acute pain through trigeminal afferent activation, with chronic pain linked to neuroplastic changes and nerve regeneration.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 8-35 with a clinical diagnosis of keratoconus seeking CXL treatment.
Not a fit: Patients with significant medical histories, psychiatric disorders, or those who are claustrophobic may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and management of pain in keratoconus patients post-CXL.
How similar studies have performed: While the approach of using neuroimaging and microscopy in this context is innovative, similar studies have shown promise in understanding pain mechanisms.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- Boston Children's Hospital — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: Eric A Moulton, OD PhD — Boston Children's Hospital
- Study coordinator: Eric A Moulton, OD PhD
- Email: eric.moulton@childrens.harvard.edu
- Phone: 617-919-6827
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pain, Postoperative, Pain, Chronic, Pain, Acute, Surgical Injury, Surgical Wound, Cornea Injury, Cornea, Keratoconus