Pain pathways and corneal nerve healing after corneal crosslinking for keratoconus
Studies brain pain pathways and corneal nerves after crosslinking in people with keratoconus.
Key facts
- Who runs it
- Boston Children's Hospital
- Where
- Boston, United StatesSee the site
- Trial code
- Registry title
- fMRI and IVCM Cornea Microscopy of CXL in Keratoconus
- Status
- Recruiting
- People taking part
- 60 people, planned
- Started
- 4 Oct 2021
- Expected to end
- Dec 2027
- Type of study
- Observational, 2 groups
- Record updated
- 19 December 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people with keratoconus (a thinning, cone-shaped cornea) who plan to have corneal crosslinking (CXL). It also looks for healthy volunteers without keratoconus as a comparison group.
- Age
- 8 to 35 years
- Sex
- All sexes
- Disease stage
- CXL group: a clinical diagnosis of keratoconus and planning CXL treatment. Comparison group: no keratoconus.
- Earlier treatment
- People who have ever worn contact lenses cannot join.
Main reasons for not taking part
- Fear of closed spaces, or unable to lie still in an MRI scanner for 60 minutes
- Weight over 285 lbs (129 kg), or magnetic implants or metal-containing tattoos on the chest or above
- Serious medical history, such as current psychiatric disorders, chronic pain, serious head injury, seizures, brain tumor, stroke, HIV-AIDs or neurological disease other than migraine
- Pregnancy, or taking prescription medicine known to cause dry eyes
- Past allergic reaction to a numbing eye drop
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- 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)
Who cannot take part
- Magnetic implants or metal-containing tattoos on their chest or above
- 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
- History of contact lens wear
- Any allergic response to a numbing eyedrop in the past
- Claustrophobic
- Weight > 285 lbs (weight limit of the MRI table)
- Pregnancy
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 8 and 35 years old?
Where in United States
- Boston Children's HospitalBoston, United StatesContact: Nicholas J Pondelis, BATaking people
About the trial
What the trial wants to find out
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).
The 2 groups in the trial
- 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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Neuroplasticity of Pain Pathways and Corneal Afferent Regeneration Following Corneal Crosslinking (CXL) in Keratoconus
- Plain-language title
- Pain pathways and corneal nerve healing after corneal crosslinking for keratoconusGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 15 November 2026.
- Fit questions
- Built from NCT04439552, who can take part
- Record updated
- 19 December 2025