Retinal ImagingPORTNCT03037268
Quality and Diagnostic Utility of Mydriatic Fundus Plenoptic Photography
An observational study of Retinal Imaging, run by Wills Eye at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Retinal Imaging
- What is being tested?
- Lytro Plenoptic Camera and 28D lens
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2018to May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing dialted examination in the Retina Service of Wills Eye Hospital
Who may be able to join
- With and without visually significant posterior retinal or optic nerve pathology,
- Pregnant women if already dilated for reason other than study participation.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mid Atlantic Retina- Wills Eye Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: Quality and Diagnostic Utility of Mydriatic Fundus Plenoptic Photography: The Plenoptic Ophthalmoscopy Reliability Trial
- 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.
- 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
Read the 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.
- Conditions
- Retinal Imaging
- Being tested
- Lytro Plenoptic Camera and 28D lens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Lytro Plenoptic Camera and 28D lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Image quality
Image quality grade (1 - 5, with 1 being excellent and 5 being not diagnostically useful)
Measured: 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)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study startDec 2018 (estimated)
- Primary completionMay 2019 (estimated)
- Study completionMay 2019 (estimated)
Why it stopped: Device is no longer available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Retinal ImagingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wills Eye
- Sponsor type
- University, hospital or other
- Collaborators
- Mid Atlantic Retina
- Responsible party
- Principal investigator, Jason Hsu, MD, Wills Eye
- Investigators
- Jason Hsu, MD, Principal investigator, Wills Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03037268
- Sponsor's protocol ID
- 14-447E
- Acronym
- PORT
- Status last verified
- Nov 2019
- First submitted
- 23 Jan 2017
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 22218140Bruce 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.
PubMed 21268749Adam 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.
PubMed 27842198
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality and Diagnostic Utility of Mydriatic Fundus Plenoptic Photography: The Plenoptic Ophthalmoscopy Reliability Trial
- ClinicalTrials.gov ID
- NCT03037268
- Acronym / sponsor ID
- PORT / 14-447E
- Conditions
- Retinal Imaging
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Device is no longer available
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wills EyeUniversity, hospital or other
- Collaborators
- Mid Atlantic Retina
- Study start
- Dec 2018 (estimated)
- Primary completion
- May 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 31 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- 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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing dilated examination | – | Device: Lytro Plenoptic Camera and 28D lens* 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing dialted examination in the Retina Service of Wills Eye Hospital
Key inclusion criteria (2 listed)
- With and without visually significant posterior retinal or optic nerve pathology,
- Pregnant women if already dilated for reason other than study participation.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Patients undergoing dilated examination |
Primary outcome
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)
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)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- Background: PubMed 22218140Lamirel 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.
- Background: PubMed 21268749Bruce 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.
- Background: PubMed 27842198Adam 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Hsu, MD principal investigator
Wills Eye Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinal Imaging, run by Wills Eye at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Image quality (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03037268, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2019; AzTrials last refreshed its copy on 8 Nov 2026.