RECRUITING

fMRI and IVCM Cornea Microscopy of CXL in Keratoconus

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Conditions

Pain, PostoperativePain, ChronicPain, AcuteSurgical InjurySurgical WoundCornea InjuryCorneaKeratoconusfMRICorneal MicroscopyIVCMNeuroimaging

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2021-10-04
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04439552

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:8 Years to 35 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 8-35 years
  2. * Clinical diagnosis of keratoconus and seeking CXL treatment
  3. * English speaking ability sufficient to comprehend consent with parental assistance
  4. * MRI compatible
  5. * Ability to lie still for an MRI session (60 minutes)
  6. * Age 8-35 years
  7. * No diagnosis of keratoconus
  8. * English speaking ability sufficient to comprehend consent with parental assistance
  9. * MRI compatible
  10. * Ability to lie still for an MRI session (60 minutes)
  11. * Claustrophobic
  12. * Weight \> 285 lbs (weight limit of the MRI table)
  13. * Significant medical history, including:
  14. * Magnetic implants or metal-containing tattoos on their chest or above
  15. * Pregnancy
  16. * History of contact lens wear
  17. * Any allergic response to a numbing eyedrop in the past
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Eric A Moulton, OD PhD
CONTACT
617-919-6827
eric.moulton@childrens.harvard.edu
Nicholas J Pondelis, BA
CONTACT
617-919-1895
nicholas.pondelis@childrens.harvard.edu

Principal Investigator

Eric A Moulton, OD PhD
PRINCIPAL_INVESTIGATOR
Boston Children's Hospital

Study Locations (Sites)

Boston Children's Hospital
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Boston Children's Hospital

  • Eric A Moulton, OD PhD, PRINCIPAL_INVESTIGATOR, Boston Children's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-04
Study Completion Date2025-12

Study Record Updates

Study Start Date2021-10-04
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • fMRI
  • Corneal Microscopy
  • IVCM
  • Neuroimaging

Additional Relevant MeSH Terms

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