What Causes Eye Pain?
Carlos Belmonte, M Carmen Acosta, Jesus Merayo-Lloves...
https://pubmed.ncbi.nlm.nih.gov/26000205Actively Recruiting
Age: 8Years - 35Years
All Genders
Healthy Volunteers
ID04439552
Neuroplasticity of Pain Pathways and Corneal Afferent Regeneration Following Corneal Crosslinking (CXL) in Keratoconus
Led by Boston Children's Hospital · Updated on 2025-12-19
60
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying changes in nerve function and regeneration after corneal crosslinking (CXL) surgery in patients with keratoconus, a condition affecting the cornea. The study aims to understand how acute pain may develop into chronic pain after CXL by using brain imaging (fMRI) and detailed corneal nerve imaging (in vivo confocal microscopy). They also want to see if biological and psychological factors can predict these pain outcomes. The study compares two groups: patients scheduled for CXL surgery and healthy volunteers matched by age and sex. Participants will undergo assessments before and after the procedure to observe nerve changes and brain activity related to pain. This observational study does not involve any treatment assignment but monitors natural changes following CXL. Participants will be involved in MRI scanning sessions lasting about 60 minutes to measure brain activity and corneal nerve structure. Researchers will use these results to evaluate neural activity related to pain and corneal nerve morphology at one year. The study requires the ability to remain still during MRI and includes both patients with keratoconus and healthy controls, with total participation lasting up to one year.
CONDITIONS
Brief Title
fMRI and IVCM Cornea Microscopy of CXL in Keratoconus
Who Can Participate
Age: 8Years - 35Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Age 8 to 35 years
- Clinical diagnosis of keratoconus and seeking CXL treatment (for CXL group)
- No diagnosis of keratoconus (for control group)
- English speaking ability sufficient to understand consent with parental help
- MRI compatible
- Ability to lie still for a 60-minute MRI session
You will not qualify if you...
- Claustrophobia
- Weight over 285 pounds (MRI table limit)
- Significant medical history including current psychiatric disorders, chronic pain, major head injury, seizures, brain tumor, stroke, neurological disease other than migraine, HIV-AIDS, or medications causing dry eyes
- Magnetic implants or metal-containing tattoos on chest or above
- Pregnancy
- History of contact lens wear
- Any allergic reaction to a numbing eyedrop
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Diagnostic Evaluation
Duration - 1 day
Participants undergo functional neuroimaging (fMRI) and in vivo corneal microscopy (IVCM) to assess neural activity and corneal nerve morphology related to pain.
1 visit (in-person)
Long-term Monitoring
Duration - 1 year
Participants are observed over 1 year to evaluate changes in neural activity and corneal nerve morphology associated with post-operative pain and corneal afferent regeneration.
Periodic assessments over 1 year
Trial Site Locations
Total: 1 location
1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Loading map...
Research Team
E
Eric A Moulton, OD PhD
N
Nicholas J Pondelis, BA
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
When pain gets stuck: the evolution of pain chronification and treatment resistance.
David Borsook, Andrew M Youssef, Laura Simons...
https://pubmed.ncbi.nlm.nih.gov/30234696In Vivo Confocal Microscopy of Corneal Nerves in Health and Disease.
Andrea Cruzat, Yureeda Qazi, Pedram Hamrah
https://pubmed.ncbi.nlm.nih.gov/27771327Recovery of the sub-basal nerve plexus and superficial nerve terminals after corneal epithelial injury in mice.
Laura E Downie, Cecilia Naranjo Golborne, Merry Chen...
https://pubmed.ncbi.nlm.nih.gov/29550279Postoperative pain after corneal collagen cross-linking.
Vinícius C Ghanem, Ramon C Ghanem, Renan de Oliveira
https://pubmed.ncbi.nlm.nih.gov/22547128Psychosocial predictors in the transition from acute to chronic pain: a systematic review.
Valerie Hruschak, Gerald Cochran
https://pubmed.ncbi.nlm.nih.gov/29490476Fear and anxiety in the transition from acute to chronic pain: there is evidence for endurance besides avoidance.
Monika I Hasenbring, Omar Chehadi, Christina Titze...
https://pubmed.ncbi.nlm.nih.gov/25350076Persistent postsurgical pain: risk factors and prevention.
Henrik Kehlet, Troels S Jensen, Clifford J Woolf
https://pubmed.ncbi.nlm.nih.gov/16698416A 48-year clinical and epidemiologic study of keratoconus.
R H Kennedy, W M Bourne, J A Dyer
https://pubmed.ncbi.nlm.nih.gov/3513592Chronic migraine is associated with reduced corneal nerve fiber density and symptoms of dry eye.
Krista I Kinard, A Gordon Smith, J Robinson Singleton...
https://pubmed.ncbi.nlm.nih.gov/25828778