MedDataX Logo

Assessment of Prototype Hand-Held Fundus Camera

NCT ID: NCT01899222

Last Updated: 2020-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-10

Study Completion Date

2015-10-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Normal Subject Population

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

fundus imaging

retinal photograph obtained at visit

Handheld fundus photography

Intervention Type DEVICE

diagnostic imaging with two types of retina camera

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Handheld fundus photography

diagnostic imaging with two types of retina camera

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

imaging only

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Rochester

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

David Kleinman

Medical Doctor and Department Faculty

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Rochester

Rochester, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HHFC 02

Identifier Type: -

Identifier Source: org_study_id