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Quality and Diagnostic Utility of Mydriatic Fundus Plenoptic Photography (PORT)

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ClinicalTrials.gov Identifier: NCT03037268
Recruitment Status : Suspended (Device is being refined by the engineers)
First Posted : January 31, 2017
Last Update Posted : March 29, 2018
Sponsor:
Collaborator:
Mid Atlantic Retina
Information provided by (Responsible Party):
Jason Hsu, MD, Wills Eye

Brief Summary:
  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

Condition or disease Intervention/treatment
Retinal Imaging Device: Lytro Plenoptic Camera and 28D lens

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Quality and Diagnostic Utility of Mydriatic Fundus Plenoptic Photography: The Plenoptic Ophthalmoscopy Reliability Trial
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Group/Cohort Intervention/treatment
Patients undergoing dilated examination
  • 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
Device: Lytro Plenoptic Camera and 28D lens
  • 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




Primary Outcome Measures :
  1. Image quality [ Time Frame: through study completion, an average of 1 year ]
    Image quality grade (1 - 5, with 1 being excellent and 5 being not diagnostically useful)

  2. Detection rate of "critical" retinal findings [ Time Frame: through study completion, an average of 1 year ]
    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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing dialted examination in the Retina Service of Wills Eye Hospital
Criteria

Inclusion Criteria:

  • With and without visually significant posterior retinal or optic nerve pathology,
  • Pregnant women if already dilated for reason other than study participation.

Exclusion Criteria:

  • Children,
  • Prisoners,
  • Poor view of posterior pole due to anterior segment pathology,
  • Poor view of posterior pole due to posterior media opacities that necessitate use of B-scan ultrasound to evaluate posterior pole.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03037268


Locations
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United States, Pennsylvania
Mid Atlantic Retina- Wills Eye Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Wills Eye
Mid Atlantic Retina
Investigators
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Principal Investigator: Jason Hsu, MD Wills Eye Hospital