Assessment of Prototype Hand-Held Fundus Camera

Normal Subject Population Clinical Trial

Official title:

Assessment of Prototype Hand-Held Fundus Camera

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01899222
• Other study ID #: HHFC 02
• Status: Completed
• Start date: April 10, 2015
• Est. completion date: October 8, 2015

Study information

• Verified date: December 2020
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: October 8, 2015
• Est. primary completion date: October 8, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Normal Subject Population

Intervention

Device:
• Handheld fundus photography
diagnostic imaging with two types of retina camera

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of photographs that score a "3" or higher on the grading scale	Photos will be evaluated by ophthalmologists and scored as follows: Unacceptable: cannot see fundus detail; Unacceptable: fundus detail visualized, but inadequate for meaningful analysis; Acceptable: fundus detail visualized enough to make general comments, with modest improvement image would be of sufficient quality for widespread use; Good: fundus detail visualized, meaningful analysis possible, standard photograph superior; Excellent: fundus detail visualized as well as standard photograph; Superior: fundus detail of higher quality than standard photograph	2-3 years