NCT03037268

Brief Summary

  1. 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. 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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 31, 2017

Completed
1.8 years until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

November 13, 2019

Status Verified

November 1, 2019

Enrollment Period

5 months

First QC Date

January 23, 2017

Last Update Submit

November 9, 2019

Conditions

Retinal Imaging

Outcome Measures

Primary Outcomes (2)

  • Image quality

    Image quality grade (1 - 5, with 1 being excellent and 5 being not diagnostically useful)

    through study completion, an average of 1 year

  • Detection rate of "critical" retinal findings

    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)

    through study completion, an average of 1 year

Study Arms (1)

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

Interventions

Lytro Plenoptic Camera and 28D lensDEVICE

* 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

Patients undergoing dilated examination

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing dialted examination in the Retina Service of Wills Eye Hospital

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mid Atlantic Retina- Wills Eye Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (3)

  • 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: 22218140BACKGROUND

  • 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: 21268749BACKGROUND

  • 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: 27842198BACKGROUND

Study Officials

  • Jason Hsu, MD

    Wills Eye Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr., MD

Study Record Dates

First Submitted

January 23, 2017

First Posted

January 31, 2017

Study Start

December 1, 2018

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

November 13, 2019

Record last verified: 2019-11

Locations

US(1)