Recruiting

Corneal Crosslinking

Sponsor:

Boston Children's Hospital

Code:

NCT04439552

Conditions

Pain, Postoperative

Pain, Chronic

Pain, Acute

Surgical Injury

Surgical Wound

Eligibility Criteria

Sex: All

Age: 8 - 35

Healthy Volunteers: Accepted

Study Details

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).

Conditions

Pain, Postoperative

Pain, Chronic

Pain, Acute

Surgical Injury

Surgical Wound

Study ID

NCT04439552

Start date

Oct 4, 2021

Status verified date

Dec, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 35

Healthy Volunteers: Accepted

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

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Neural activity related to pain. [ Time Frame: 1 year ]
  • Corneal nerve morphology. [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Eric A Moulton, OD PhD

617-919-6827eric.moulton@childrens.harvard.edu

Nicholas J Pondelis, BA

617-919-1895nicholas.pondelis@childrens.harvard.edu

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Nicholas J Pondelis, BA

617-919-1895nicholas.pondelis@childrens.harvard.edu

More Information

Sponsor

Boston Children's Hospital

Last update posted

Dec 19, 2025

Last verified

Dec, 2025

Keywords

  • fMRI
  • Corneal Microscopy
  • IVCM
  • Neuroimaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2025-12-19.