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Assessment of Prototype Hand-Held Fundus Camera

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ClinicalTrials.gov Identifier: NCT01899222
Recruitment Status : Active, not recruiting
First Posted : July 15, 2013
Last Update Posted : December 8, 2017
Sponsor:
Information provided by (Responsible Party):
David Kleinman, University of Rochester

Brief Summary:
Assessment of handheld fundus images in comparison to conventional fundus camera images.

Condition or disease Intervention/treatment Phase
Normal Subject Population Device: Handheld fundus photography Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Assessment of Prototype Hand-Held Fundus Camera
Study Start Date : April 2015
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Arm Intervention/treatment
Experimental: Subjects imaged with handheld fundus camera
Subjects imaged with handheld fundus camera
Device: Handheld fundus photography



Primary Outcome Measures :
  1. Do photographs taken with the novel handhelf fundus camera show non-inferiority to the photographs taken with the conventional technology currently in use as standard of care? [ Time Frame: 2-3 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01899222


Locations
United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester

Responsible Party: David Kleinman, Medical Doctor and Department Faculty, University of Rochester
ClinicalTrials.gov Identifier: NCT01899222     History of Changes
Other Study ID Numbers: HHFC 02
First Posted: July 15, 2013    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: December 2017