<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/NCT03037268</url>
  </required_header>
  <id_info>
    <org_study_id>14-447E</org_study_id>
    <nct_id>NCT03037268</nct_id>
  </id_info>
  <brief_title>Quality and Diagnostic Utility of Mydriatic Fundus Plenoptic Photography</brief_title>
  <acronym>PORT</acronym>
  <official_title>Quality and Diagnostic Utility of Mydriatic Fundus Plenoptic Photography: The Plenoptic Ophthalmoscopy Reliability Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wills Eye</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mid Atlantic Retina</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Wills Eye</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      1. Establish the quality of fundus images produced by plenoptic ophthalmoscopy using the&#xD;
           grading system proposed and utilized in the Fundus Photography versus Ophthalmoscopy&#xD;
           Trials Outcomes in the Emergency Department (FOTO-ED) Study.&#xD;
&#xD;
        2. Determine diagnostic utility of plenoptic ophthalmoscopy images by comparing masked&#xD;
           image reviewers' quality measurements and findings to images obtained with a&#xD;
           commercially available ocular fundus camera and documented exam findings&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Visualization of the ocular fundus is considered an essential part of the physical&#xD;
      examination, as abnormalities of the optic nerve, retinal vessels, and macula can reveal&#xD;
      underlying systemic diseases and explain the etiology of visual complaints.&#xD;
&#xD;
      The Fundus Photography versus Ophthalmoscopy Trials Outcomes in the Emergency Department&#xD;
      (FOTO-ED) Study demonstrated that only 14% of patients with complaints and conditions in&#xD;
      which fundus examination is considered important had direct ophthalmoscopy performed by an ED&#xD;
      physician .Greater than 80% of previously unknown fundus findings relevant to ED patient&#xD;
      management were missed by ED physicians, but were identified by nonmydriatic digital fundus&#xD;
      photography. Several of these cases resulted in recall of a discharged patient back to the ED&#xD;
      for hospital admission once diagnostic fundus photos were reviewed.&#xD;
&#xD;
      In the search for an alternative to improve ease of use and fundus image quality, plenoptic&#xD;
      technology provides a promising option for portable fundus imaging. Plenoptic, or light&#xD;
      field, imaging has recently been introduced commercially with the release of the Lytro&#xD;
      Plenoptic Camera (Mountain View, CA, USA). Utilizing an array of microlenses, the Lytro&#xD;
      camera captures all available light in a scene from multiple vectors. By dividing up a scene&#xD;
      as a whole with many individual microlenses, images can be refocused in post processing after&#xD;
      acquisition, sharp focus can be attained in low light situations, and stereo images with&#xD;
      perspective shifting can be attained.&#xD;
&#xD;
      To date there have been no published quantitative descriptions of the quality and reliability&#xD;
      of plenoptic ophthalmoscopy using a commercially available, portable light field camera.&#xD;
      Initial work from a pilot study using animal and human eyes was published in 2016. The&#xD;
      purpose of the proposed prospective, cross sectional imaging study is to compare standard&#xD;
      mydriatic fundus photography to a second generation camera developed with a Lytro plenoptic&#xD;
      camera and customized light source, specifically analyzing diagnostic utility/sensitivity of&#xD;
      detecting retinal pathology and overall image quality. If the image quality outcomes of the&#xD;
      investigators proposed study are similar to those of the nonmydriatic fundus camera, the&#xD;
      implications for physicians and the potential applications to ophthalmology related&#xD;
      telemedicine are significant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Device is no longer available&#xD;
  </why_stopped>
  <start_date type="Anticipated">December 2018</start_date>
  <completion_date type="Anticipated">May 2019</completion_date>
  <primary_completion_date type="Anticipated">May 2019</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Image quality</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Image quality grade (1 - 5, with 1 being excellent and 5 being not diagnostically useful)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Detection rate of &quot;critical&quot; retinal findings</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Sensitivity (%) of detection of &quot;critical&quot; retinal findings with plenoptic ophthalmoscopy. Critical retinal findings include retinal detachment, retinal vascular sheathing, retinal hemorrhage, retinal whitening, optic disc edema, optic disc pallor, optic disc cupping (&gt; 0.5 cup-to disc ratio)</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Retinal Imaging</condition>
  <arm_group>
    <arm_group_label>Patients undergoing dilated examination</arm_group_label>
    <description>examined in the Retina Service of Wills Eye Hospital&#xD;
with and without visually significant posterior retinal or optic nerve pathology&#xD;
imaged with a Lytro Plenoptic Camera and 28D lens</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Lytro Plenoptic Camera and 28D lens</intervention_name>
    <description>visual acuity measured, intraocular pressure obtained, eyes dilated as part of a standard exam for intended patient visit&#xD;
screened and consented for study&#xD;
subjected to bilateral plenoptic ophthalmoscopy&#xD;
mydriatic, single-field fundus images obtained&#xD;
images reviewed for quality and diagnostic utility by a masked grader</description>
    <arm_group_label>Patients undergoing dilated examination</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing dialted examination in the Retina Service of Wills Eye Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  With and without visually significant posterior retinal or optic nerve pathology,&#xD;
&#xD;
          -  Pregnant women if already dilated for reason other than study participation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children,&#xD;
&#xD;
          -  Prisoners,&#xD;
&#xD;
          -  Poor view of posterior pole due to anterior segment pathology,&#xD;
&#xD;
          -  Poor view of posterior pole due to posterior media opacities that necessitate use of&#xD;
             B-scan ultrasound to evaluate posterior pole.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jason Hsu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wills Eye Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mid Atlantic Retina- Wills Eye Institute</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Lamirel C, Bruce BB, Wright DW, Delaney KP, Newman NJ, Biousse V. Quality of nonmydriatic digital fundus photography obtained by nurse practitioners in the emergency department: the FOTO-ED study. Ophthalmology. 2012 Mar;119(3):617-24. doi: 10.1016/j.ophtha.2011.09.013. Epub 2012 Jan 3.</citation>
    <PMID>22218140</PMID>
  </reference>
  <reference>
    <citation>Bruce BB, Lamirel C, Wright DW, Ward A, Heilpern KL, Biousse V, Newman NJ. Nonmydriatic ocular fundus photography in the emergency department. N Engl J Med. 2011 Jan 27;364(4):387-9. doi: 10.1056/NEJMc1009733. No abstract available.</citation>
    <PMID>21268749</PMID>
  </reference>
  <reference>
    <citation>Adam MK, Aenchbacher W, Kurzweg T, Hsu J. Plenoptic Ophthalmoscopy: A Novel Imaging Technique. Ophthalmic Surg Lasers Imaging Retina. 2016 Nov 1;47(11):1038-1043. doi: 10.3928/23258160-20161031-08.</citation>
    <PMID>27842198</PMID>
  </reference>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>January 23, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>November 9, 2019</last_update_submitted>
  <last_update_submitted_qc>November 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wills Eye</investigator_affiliation>
    <investigator_full_name>Jason Hsu, MD</investigator_full_name>
    <investigator_title>Dr., MD</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03037268
org study id: 14-447E
nct id: NCT03037268
lead sponsor: 
collaborator: 
has dmc: No
1. Establish the quality of fundus images produced by plenoptic ophthalmoscopy using the
           grading system proposed and utilized in the Fundus Photography versus Ophthalmoscopy
           Trials Outcomes in the Emergency Department (FOTO-ED) Study.

        2. Determine diagnostic utility of plenoptic ophthalmoscopy images by comparing masked
           image reviewers' quality measurements and findings to images obtained with a
           commercially available ocular fundus camera and documented exam findings
Visualization of the ocular fundus is considered an essential part of the physical
      examination, as abnormalities of the optic nerve, retinal vessels, and macula can reveal
      underlying systemic diseases and explain the etiology of visual complaints.

      The Fundus Photography versus Ophthalmoscopy Trials Outcomes in the Emergency Department
      (FOTO-ED) Study demonstrated that only 14% of patients with complaints and conditions in
      which fundus examination is considered important had direct ophthalmoscopy performed by an ED
      physician .Greater than 80% of previously unknown fundus findings relevant to ED patient
      management were missed by ED physicians, but were identified by nonmydriatic digital fundus
      photography. Several of these cases resulted in recall of a discharged patient back to the ED
      for hospital admission once diagnostic fundus photos were reviewed.

      In the search for an alternative to improve ease of use and fundus image quality, plenoptic
      technology provides a promising option for portable fundus imaging. Plenoptic, or light
      field, imaging has recently been introduced commercially with the release of the Lytro
      Plenoptic Camera (Mountain View, CA, USA). Utilizing an array of microlenses, the Lytro
      camera captures all available light in a scene from multiple vectors. By dividing up a scene
      as a whole with many individual microlenses, images can be refocused in post processing after
      acquisition, sharp focus can be attained in low light situations, and stereo images with
      perspective shifting can be attained.

      To date there have been no published quantitative descriptions of the quality and reliability
      of plenoptic ophthalmoscopy using a commercially available, portable light field camera.
      Initial work from a pilot study using animal and human eyes was published in 2016. The
      purpose of the proposed prospective, cross sectional imaging study is to compare standard
      mydriatic fundus photography to a second generation camera developed with a Lytro plenoptic
      camera and customized light source, specifically analyzing diagnostic utility/sensitivity of
      detecting retinal pathology and overall image quality. If the image quality outcomes of the
      investigators proposed study are similar to those of the nonmydriatic fundus camera, the
      implications for physicians and the potential applications to ophthalmology related
      telemedicine are significant.
observational model: Cohort
time perspective: Cross-Sectional
measure: Image quality
time frame: through study completion, an average of 1 year
description: Image quality grade (1 - 5, with 1 being excellent and 5 being not diagnostically useful)
measure: Detection rate of "critical" retinal findings
time frame: through study completion, an average of 1 year
description: Sensitivity (%) of detection of "critical" retinal findings with plenoptic ophthalmoscopy. Critical retinal findings include retinal detachment, retinal vascular sheathing, retinal hemorrhage, retinal whitening, optic disc edema, optic disc pallor, optic disc cupping (> 0.5 cup-to disc ratio)
arm group label: Patients undergoing dilated examination
description: examined in the Retina Service of Wills Eye Hospital
with and without visually significant posterior retinal or optic nerve pathology
imaged with a Lytro Plenoptic Camera and 28D lens
intervention type: Device
intervention name: Lytro Plenoptic Camera and 28D lens
description: visual acuity measured, intraocular pressure obtained, eyes dilated as part of a standard exam for intended patient visit
screened and consented for study
subjected to bilateral plenoptic ophthalmoscopy
mydriatic, single-field fundus images obtained
images reviewed for quality and diagnostic utility by a masked grader
arm group label: Patients undergoing dilated examination
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jason Hsu, MD
role: Principal Investigator
affiliation: Wills Eye Hospital
facility: 
country: United States
citation: Lamirel C, Bruce BB, Wright DW, Delaney KP, Newman NJ, Biousse V. Quality of nonmydriatic digital fundus photography obtained by nurse practitioners in the emergency department: the FOTO-ED study. Ophthalmology. 2012 Mar;119(3):617-24. doi: 10.1016/j.ophtha.2011.09.013. Epub 2012 Jan 3.
PMID: 22218140
citation: Bruce BB, Lamirel C, Wright DW, Ward A, Heilpern KL, Biousse V, Newman NJ. Nonmydriatic ocular fundus photography in the emergency department. N Engl J Med. 2011 Jan 27;364(4):387-9. doi: 10.1056/NEJMc1009733. No abstract available.
PMID: 21268749
citation: Adam MK, Aenchbacher W, Kurzweg T, Hsu J. Plenoptic Ophthalmoscopy: A Novel Imaging Technique. Ophthalmic Surg Lasers Imaging Retina. 2016 Nov 1;47(11):1038-1043. doi: 10.3928/23258160-20161031-08.
PMID: 27842198
responsible party type: Principal Investigator
investigator affiliation: Wills Eye
investigator full name: Jason Hsu, MD
investigator title: Dr., MD
sharing ipd: Undecided