WithdrawnNot Applicable

Quality and Diagnostic Utility of Mydriatic Fundus Plenoptic Photography

Stopped: Device is no longer available

United States0Started 2018-12

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Image quality

Timeframe: through study completion, an average of 1 year

Detection rate of "critical" retinal findings

Timeframe: through study completion, an average of 1 year

Trial details

NCT IDNCT03037268

SponsorWills Eye

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-05

View on ClinicalTrials.gov More Retinal Imaging trials