Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
60 participants
OBSERVATIONAL
2021-10-04
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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CXL group
Patients who are about to undergo a corneal cross-linking (CXL) surgery to treat keratoconus.
No interventions assigned to this group
Control group
Healthy volunteers age and sex matched to the CXL group.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
8 Years
35 Years
ALL
Yes
Sponsors
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Boston Children's Hospital
OTHER
Responsible Party
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Eric Moulton
Assistant Professor of Anesthesia
Principal Investigators
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Eric A Moulton, OD PhD
Role: PRINCIPAL_INVESTIGATOR
Boston Children's Hospital
Locations
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Boston Children's Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Nicholas J Pondelis, BA
Role: primary
References
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Cruzat A, Qazi Y, Hamrah P. In Vivo Confocal Microscopy of Corneal Nerves in Health and Disease. Ocul Surf. 2017 Jan;15(1):15-47. doi: 10.1016/j.jtos.2016.09.004. Epub 2016 Oct 19.
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Kinard KI, Smith AG, Singleton JR, Lessard MK, Katz BJ, Warner JE, Crum AV, Mifflin MD, Brennan KC, Digre KB. Chronic migraine is associated with reduced corneal nerve fiber density and symptoms of dry eye. Headache. 2015 Apr;55(4):543-9. doi: 10.1111/head.12547. Epub 2015 Mar 31.
Larbig W, Andoh J, Huse E, Stahl-Corino D, Montoya P, Seltzer Z, Flor H. Pre- and postoperative predictors of phantom limb pain. Neurosci Lett. 2019 May 29;702:44-50. doi: 10.1016/j.neulet.2018.11.044. Epub 2018 Nov 29.
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Moulton EA, Borsook D. C-Fiber Assays in the Cornea vs. Skin. Brain Sci. 2019 Nov 12;9(11):320. doi: 10.3390/brainsci9110320.
Rosenthal P, Borsook D, Moulton EA. Oculofacial Pain: Corneal Nerve Damage Leading to Pain Beyond the Eye. Invest Ophthalmol Vis Sci. 2016 Oct 1;57(13):5285-5287. doi: 10.1167/iovs.16-20557.
Schiffman RM, Christianson MD, Jacobsen G, Hirsch JD, Reis BL. Reliability and validity of the Ocular Surface Disease Index. Arch Ophthalmol. 2000 May;118(5):615-21. doi: 10.1001/archopht.118.5.615.
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Tervo K, Latvala TM, Tervo TM. Recovery of corneal innervation following photorefractive keratoablation. Arch Ophthalmol. 1994 Nov;112(11):1466-70. doi: 10.1001/archopht.1994.01090230080025.
Pondelis NJ, Moulton EA. Supraspinal Mechanisms Underlying Ocular Pain. Front Med (Lausanne). 2022 Feb 8;8:768649. doi: 10.3389/fmed.2021.768649. eCollection 2021.
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Other Identifiers
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IRB-P00035185
Identifier Type: -
Identifier Source: org_study_id