<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04439552</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-P00035185</org_study_id>
    <nct_id>NCT04439552</nct_id>
  </id_info>
  <brief_title>fMRI and IVCM Cornea Microscopy of CXL in Keratoconus</brief_title>
  <official_title>Neuroplasticity of Pain Pathways and Corneal Afferent Regeneration Following Corneal Crosslinking (CXL) in Keratoconus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Children's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluation of neuroplasticity of pain pathways and corneal afferent nerve regeneration&#xD;
      following corneal crosslinking (CXL) in keratoconus patients using fMRI and corneal In Vivo&#xD;
      Confocal Microscopy (IVCM).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Our long-term goal is to evaluate the transition from acute to chronic pain that sometimes&#xD;
      occurs following CXL in keratoconus patients. This study will determine whether these changes&#xD;
      can be structurally and functionally quantified using functional neuroimaging and in vivo&#xD;
      corneal microscopy (IVCM), and whether they can be predicted based on predisposing biological&#xD;
      and psychological factors. Our central hypothesis is that CXL produces acute pain through&#xD;
      activation of trigeminal afferents, and that post-operative chronic pain outcomes are related&#xD;
      to neuroplastic changes in trigeminal circuitry, corneal afferent regeneration, and&#xD;
      psychological factors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 4, 2021</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">August 2025</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Neural activity related to pain.</measure>
    <time_frame>1 year</time_frame>
    <description>Pain-related brain activation measured with fMRI.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Corneal nerve morphology.</measure>
    <time_frame>1 year</time_frame>
    <description>Afferent nerve fiber morphology measured with IVCM.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Pain, Postoperative</condition>
  <condition>Pain, Chronic</condition>
  <condition>Pain, Acute</condition>
  <condition>Surgical Injury</condition>
  <condition>Surgical Wound</condition>
  <condition>Cornea Injury</condition>
  <condition>Cornea</condition>
  <condition>Keratoconus</condition>
  <arm_group>
    <arm_group_label>CXL group</arm_group_label>
    <description>Patients who are about to undergo a corneal cross-linking (CXL) surgery to treat keratoconus.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>Healthy volunteers age and sex matched to the CXL group.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The population under study are patients with keratoconus who are undergoing a corneal&#xD;
        cross-linking (CXL) procedure. Keratoconus is an eye condition where the cornea&#xD;
        progressively develops abnormally into a cone shape, which can lead to distorted vision and&#xD;
        irreversible vision loss The CXL procedure is designed to restore and maintain the shape of&#xD;
        the cornea to avoid these complications.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        CXL Group&#xD;
&#xD;
          -  Age 8-35 years&#xD;
&#xD;
          -  Clinical diagnosis of keratoconus and seeking CXL treatment&#xD;
&#xD;
          -  English speaking ability sufficient to comprehend consent with parental assistance&#xD;
&#xD;
          -  MRI compatible&#xD;
&#xD;
          -  Ability to lie still for an MRI session (60 minutes)&#xD;
&#xD;
        Control Group&#xD;
&#xD;
          -  Age 8-35 years&#xD;
&#xD;
          -  No diagnosis of keratoconus&#xD;
&#xD;
          -  English speaking ability sufficient to comprehend consent with parental assistance&#xD;
&#xD;
          -  MRI compatible&#xD;
&#xD;
          -  Ability to lie still for an MRI session (60 minutes)&#xD;
&#xD;
        Exclusion Criteria (Both Groups):&#xD;
&#xD;
          -  Claustrophobic&#xD;
&#xD;
          -  Weight &gt; 285 lbs (weight limit of the MRI table)&#xD;
&#xD;
          -  Significant medical history, including:&#xD;
&#xD;
        Current DSM-IV-TR axis I psychiatric disorders. Chronic pain Significant head injury&#xD;
        Seizures Brain tumor Cerebrovascular accident Neurological disease aside from migraine&#xD;
        HIV-AIDs Prescription medication strongly implicated in causing dry eyes&#xD;
&#xD;
          -  Magnetic implants or metal-containing tattoos on their chest or above&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  History of contact lens wear&#xD;
&#xD;
          -  Any allergic response to a numbing eyedrop in the past&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric A Moulton, OD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Children's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Eric A Moulton, OD PhD</last_name>
    <phone>617-919-6827</phone>
    <email>eric.moulton@childrens.harvard.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Nicholas J Pondelis, BA</last_name>
    <phone>617-919-1895</phone>
    <email>nicholas.pondelis@childrens.harvard.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Boston Children's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nicholas J Pondelis, BA</last_name>
      <phone>617-919-1895</phone>
      <email>nicholas.pondelis@childrens.harvard.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Belmonte C, Acosta MC, Merayo-Lloves J, Gallar J. What Causes Eye Pain? Curr Ophthalmol Rep. 2015;3(2):111-121. doi: 10.1007/s40135-015-0073-9.</citation>
    <PMID>26000205</PMID>
  </reference>
  <reference>
    <citation>Borsook D, Youssef AM, Simons L, Elman I, Eccleston C. When pain gets stuck: the evolution of pain chronification and treatment resistance. Pain. 2018 Dec;159(12):2421-2436. doi: 10.1097/j.pain.0000000000001401.</citation>
    <PMID>30234696</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>27771327</PMID>
  </reference>
  <reference>
    <citation>Downie LE, Naranjo Golborne C, Chen M, Ho N, Hoac C, Liyanapathirana D, Luo C, Wu RB, Chinnery HR. Recovery of the sub-basal nerve plexus and superficial nerve terminals after corneal epithelial injury in mice. Exp Eye Res. 2018 Jun;171:92-100. doi: 10.1016/j.exer.2018.03.012. Epub 2018 Mar 14.</citation>
    <PMID>29550279</PMID>
  </reference>
  <reference>
    <citation>Ghanem VC, Ghanem RC, de Oliveira R. Postoperative pain after corneal collagen cross-linking. Cornea. 2013 Jan;32(1):20-4. doi: 10.1097/ICO.0b013e31824d6fe3.</citation>
    <PMID>22547128</PMID>
  </reference>
  <reference>
    <citation>Hruschak V, Cochran G. Psychosocial predictors in the transition from acute to chronic pain: a systematic review. Psychol Health Med. 2018 Dec;23(10):1151-1167. doi: 10.1080/13548506.2018.1446097. Epub 2018 Feb 28.</citation>
    <PMID>29490476</PMID>
  </reference>
  <reference>
    <citation>Hasenbring MI, Chehadi O, Titze C, Kreddig N. Fear and anxiety in the transition from acute to chronic pain: there is evidence for endurance besides avoidance. Pain Manag. 2014;4(5):363-74. doi: 10.2217/pmt.14.36.</citation>
    <PMID>25350076</PMID>
  </reference>
  <reference>
    <citation>Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X.</citation>
    <PMID>16698416</PMID>
  </reference>
  <reference>
    <citation>Kennedy RH, Bourne WM, Dyer JA. A 48-year clinical and epidemiologic study of keratoconus. Am J Ophthalmol. 1986 Mar 15;101(3):267-73. doi: 10.1016/0002-9394(86)90817-2.</citation>
    <PMID>3513592</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>25828778</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>30503915</PMID>
  </reference>
  <reference>
    <citation>Moulton EA, Becerra L, Borsook D. An fMRI case report of photophobia: activation of the trigeminal nociceptive pathway. Pain. 2009 Oct;145(3):358-363. doi: 10.1016/j.pain.2009.07.018. Epub 2009 Aug 11.</citation>
    <PMID>19674842</PMID>
  </reference>
  <reference>
    <citation>Moulton EA, Borsook D. C-Fiber Assays in the Cornea vs. Skin. Brain Sci. 2019 Nov 12;9(11):320. doi: 10.3390/brainsci9110320.</citation>
    <PMID>31718074</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>27723896</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>10815152</PMID>
  </reference>
  <reference>
    <citation>Simone DA, Nolano M, Johnson T, Wendelschafer-Crabb G, Kennedy WR. Intradermal injection of capsaicin in humans produces degeneration and subsequent reinnervation of epidermal nerve fibers: correlation with sensory function. J Neurosci. 1998 Nov 1;18(21):8947-59. doi: 10.1523/JNEUROSCI.18-21-08947.1998.</citation>
    <PMID>9787000</PMID>
  </reference>
  <reference>
    <citation>Sjoberg J, Kanje M. The initial period of peripheral nerve regeneration and the importance of the local environment for the conditioning lesion effect. Brain Res. 1990 Oct 8;529(1-2):79-84. doi: 10.1016/0006-8993(90)90812-p.</citation>
    <PMID>2282506</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>7980137</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>35211480</PMID>
  </reference>
  <reference>
    <citation>van der Valk Bouman ES, Pump H, Borsook D, Severinsky B, Wisse RP, Saeed HN, Moulton EA. Pain mechanisms and management in corneal cross-linking: a review. BMJ Open Ophthalmol. 2021 Nov 29;6(1):e000878. doi: 10.1136/bmjophth-2021-000878. eCollection 2021.</citation>
    <PMID>34901466</PMID>
  </reference>
  <reference>
    <citation>Dieckmann G, Borsook D, Moulton E. Neuropathic corneal pain and dry eye: a continuum of nociception. Br J Ophthalmol. 2022 Aug;106(8):1039-1043. doi: 10.1136/bjophthalmol-2020-318469. Epub 2021 Apr 30.</citation>
    <PMID>33931393</PMID>
  </reference>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>December 7, 2022</last_update_submitted>
  <last_update_submitted_qc>December 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston Children's Hospital</investigator_affiliation>
    <investigator_full_name>Eric Moulton</investigator_full_name>
    <investigator_title>Assistant Professor of Anesthesia</investigator_title>
  </responsible_party>
  <keyword>fMRI</keyword>
  <keyword>Corneal Microscopy</keyword>
  <keyword>IVCM</keyword>
  <keyword>Neuroimaging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Corneal Injuries</mesh_term>
    <mesh_term>Keratoconus</mesh_term>
    <mesh_term>Corneal Diseases</mesh_term>
    <mesh_term>Pain, Postoperative</mesh_term>
    <mesh_term>Chronic Pain</mesh_term>
    <mesh_term>Intraoperative Complications</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Surgical Wound</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All IPD that underlie results in a publication</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Starting 6 months after publication, until 5 years after.</ipd_time_frame>
    <ipd_access_criteria>Direct request to study personnel via email, letter, phone, or in-person communication. Information will be shared with requesting parties for the purposes of expanding on this research or re-analysis. Neuroimaging data and corneal microscopy data will be shared via secure digital electronic transfer.</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04439552
org study id: IRB-P00035185
nct id: NCT04439552
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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).
Our long-term goal is to evaluate the transition from acute to chronic pain that sometimes
      occurs following CXL in keratoconus patients. This study will determine whether these changes
      can be structurally and functionally quantified using functional neuroimaging and in vivo
      corneal microscopy (IVCM), and whether they can be predicted based on predisposing biological
      and psychological factors. Our central hypothesis is that CXL produces acute pain through
      activation of trigeminal afferents, and that post-operative chronic pain outcomes are related
      to neuroplastic changes in trigeminal circuitry, corneal afferent regeneration, and
      psychological factors.
observational model: Cohort
time perspective: Prospective
measure: Neural activity related to pain.
time frame: 1 year
description: Pain-related brain activation measured with fMRI.
measure: Corneal nerve morphology.
time frame: 1 year
description: Afferent nerve fiber morphology measured with IVCM.
arm group label: CXL group
description: Patients who are about to undergo a corneal cross-linking (CXL) surgery to treat keratoconus.
arm group label: Control group
description: Healthy volunteers age and sex matched to the CXL group.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 8 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Eric A Moulton, OD PhD
role: Principal Investigator
affiliation: Boston Children's Hospital
last name: Eric A Moulton, OD PhD
phone: 617-919-6827
email: eric.moulton@childrens.harvard.edu
last name: Nicholas J Pondelis, BA
phone: 617-919-1895
email: nicholas.pondelis@childrens.harvard.edu
facility: 
status: Recruiting
contact: 
country: United States
citation: Belmonte C, Acosta MC, Merayo-Lloves J, Gallar J. What Causes Eye Pain? Curr Ophthalmol Rep. 2015;3(2):111-121. doi: 10.1007/s40135-015-0073-9.
PMID: 26000205
citation: Borsook D, Youssef AM, Simons L, Elman I, Eccleston C. When pain gets stuck: the evolution of pain chronification and treatment resistance. Pain. 2018 Dec;159(12):2421-2436. doi: 10.1097/j.pain.0000000000001401.
PMID: 30234696
citation: 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.
PMID: 27771327
citation: Downie LE, Naranjo Golborne C, Chen M, Ho N, Hoac C, Liyanapathirana D, Luo C, Wu RB, Chinnery HR. Recovery of the sub-basal nerve plexus and superficial nerve terminals after corneal epithelial injury in mice. Exp Eye Res. 2018 Jun;171:92-100. doi: 10.1016/j.exer.2018.03.012. Epub 2018 Mar 14.
PMID: 29550279
citation: Ghanem VC, Ghanem RC, de Oliveira R. Postoperative pain after corneal collagen cross-linking. Cornea. 2013 Jan;32(1):20-4. doi: 10.1097/ICO.0b013e31824d6fe3.
PMID: 22547128
citation: Hruschak V, Cochran G. Psychosocial predictors in the transition from acute to chronic pain: a systematic review. Psychol Health Med. 2018 Dec;23(10):1151-1167. doi: 10.1080/13548506.2018.1446097. Epub 2018 Feb 28.
PMID: 29490476
citation: Hasenbring MI, Chehadi O, Titze C, Kreddig N. Fear and anxiety in the transition from acute to chronic pain: there is evidence for endurance besides avoidance. Pain Manag. 2014;4(5):363-74. doi: 10.2217/pmt.14.36.
PMID: 25350076
citation: Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X.
PMID: 16698416
citation: Kennedy RH, Bourne WM, Dyer JA. A 48-year clinical and epidemiologic study of keratoconus. Am J Ophthalmol. 1986 Mar 15;101(3):267-73. doi: 10.1016/0002-9394(86)90817-2.
PMID: 3513592
citation: 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.
PMID: 25828778
citation: 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.
PMID: 30503915
citation: Moulton EA, Becerra L, Borsook D. An fMRI case report of photophobia: activation of the trigeminal nociceptive pathway. Pain. 2009 Oct;145(3):358-363. doi: 10.1016/j.pain.2009.07.018. Epub 2009 Aug 11.
PMID: 19674842
citation: Moulton EA, Borsook D. C-Fiber Assays in the Cornea vs. Skin. Brain Sci. 2019 Nov 12;9(11):320. doi: 10.3390/brainsci9110320.
PMID: 31718074
citation: 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.
PMID: 27723896
citation: 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.
PMID: 10815152
citation: Simone DA, Nolano M, Johnson T, Wendelschafer-Crabb G, Kennedy WR. Intradermal injection of capsaicin in humans produces degeneration and subsequent reinnervation of epidermal nerve fibers: correlation with sensory function. J Neurosci. 1998 Nov 1;18(21):8947-59. doi: 10.1523/JNEUROSCI.18-21-08947.1998.
PMID: 9787000
citation: Sjoberg J, Kanje M. The initial period of peripheral nerve regeneration and the importance of the local environment for the conditioning lesion effect. Brain Res. 1990 Oct 8;529(1-2):79-84. doi: 10.1016/0006-8993(90)90812-p.
PMID: 2282506
citation: 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.
PMID: 7980137
citation: 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.
PMID: 35211480
citation: van der Valk Bouman ES, Pump H, Borsook D, Severinsky B, Wisse RP, Saeed HN, Moulton EA. Pain mechanisms and management in corneal cross-linking: a review. BMJ Open Ophthalmol. 2021 Nov 29;6(1):e000878. doi: 10.1136/bmjophth-2021-000878. eCollection 2021.
PMID: 34901466
citation: Dieckmann G, Borsook D, Moulton E. Neuropathic corneal pain and dry eye: a continuum of nociception. Br J Ophthalmol. 2022 Aug;106(8):1039-1043. doi: 10.1136/bjophthalmol-2020-318469. Epub 2021 Apr 30.
PMID: 33931393
responsible party type: Principal Investigator
investigator affiliation: Boston Children's Hospital
investigator full name: Eric Moulton
investigator title: Assistant Professor of Anesthesia
mesh term: Corneal Injuries
mesh term: Keratoconus
mesh term: Corneal Diseases
mesh term: Pain, Postoperative
mesh term: Chronic Pain
mesh term: Intraoperative Complications
mesh term: Wounds and Injuries
mesh term: Surgical Wound
sharing ipd: Yes
ipd description: All IPD that underlie results in a publication
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Starting 6 months after publication, until 5 years after.
ipd access criteria: Direct request to study personnel via email, letter, phone, or in-person communication. Information will be shared with requesting parties for the purposes of expanding on this research or re-analysis. Neuroimaging data and corneal microscopy data will be shared via secure digital electronic transfer.