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Assessment of Prototype Hand-Held Fundus Camera

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01899222
First Posted: July 15, 2013
Last Update Posted: December 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
David Kleinman, University of Rochester
  Purpose
Assessment of handheld fundus images in comparison to conventional fundus camera images.

Condition Intervention
Normal Subject Population Device: Handheld fundus photography

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Assessment of Prototype Hand-Held Fundus Camera

Further study details as provided by David Kleinman, University of Rochester:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
Study Start Date: April 2015
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Subjects imaged with handheld fundus camera
Subjects imaged with handheld fundus camera
Device: Handheld fundus photography

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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
  More Information

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 Submitted: July 12, 2013
First Posted: July 15, 2013
Last Update Posted: December 8, 2017
Last Verified: December 2017