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Assessment of Prototype Hand-Held Fundus Camera

Assessment of Prototype Hand-Held Fundus Camera

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01899222
Enrollment
8
Registered
2013-07-15
Start date
2015-04-10
Completion date
2015-10-08
Last updated
2020-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Normal Subject Population

Brief summary

Assessment of handheld fundus images in comparison to conventional fundus camera images.

Detailed description

This study is comparing a small handheld camera with a standard fundus camera for image quality

Interventions

DEVICEHandheld fundus photography

diagnostic imaging with two types of retina camera

Sponsors

University of Rochester
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Age \> 18 * The ability to give informed consent and be willing to spend up to two hours in the eye clinic during the duration of the study. * The subjects may have a normal retina and optic nerve, or subjects may have abnormalities of the posterior pole of the retina or the optic nerve.

Exclusion criteria

* Medical or ophthalmic instability that would create a contraindication for minimally invasive ophthalmic diagnostic testing will exclude participation as a subject. * Ophthalmic pathology felt by the principal investigator that would make retinal imaging with standard photographs difficult or not possible.

Design outcomes

Primary

MeasureTime frameDescription
Percentage of photographs that score a 3 or higher on the grading scale2-3 yearsPhotos will be evaluated by ophthalmologists and scored as follows: 1. Unacceptable: cannot see fundus detail 2. Unacceptable: fundus detail visualized, but inadequate for meaningful analysis 3. Acceptable: fundus detail visualized enough to make general comments, with modest improvement image would be of sufficient quality for widespread use 4. Good: fundus detail visualized, meaningful analysis possible, standard photograph superior 5. Excellent: fundus detail visualized as well as standard photograph 6. Superior: fundus detail of higher quality than standard photograph

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026