Smartphone-based Ophthalmoscopy

June 26, 2014 updated by: Andrea Russo, Università degli Studi di Brescia

Comparison of Smartphone-based Ophthalmoscopy Versus Dilated Ophthalmic Examination for Diabetic and Nondiabetic Eye Disease

A subset of 120 diabetic patients underwent dilated examination and smartphone ophthalmoscopy. The smartphone was equipped with a compact add-on that filtered and delivered the smartphone's LED light coaxially to the camera, allowing a clear and convenient view of the retina.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • BS
      • Brescia, BS, Italy, 25123
        • Spedali Civili di Brescia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • type 1 or 2 diabetes
  • ability to provide written informed consent

Exclusion Criteria:

  • significant optic media opacities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diabet patients
Smartphone ophthalmoscopy followed by traditional slit-lamp dilated ophthalmoscopy
Device: Smartphone
Other: Ophthalmoscopy conducted using a smartphone equipped with a compact addon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diabetic retinopathy grading
Time Frame: The same day as dilated ophthalmic examination

The grading was performed according to the Early Treatment Diabetic Retinopathy Study (ETDRS) diabetic retinopathy classification.

Grade 0: no diabetic retinopathy Grade 1: mild non-proliferative diabetic retinopathy Grade 2: average non-proliferative diabetic retinopathy Grade 3: severe non-proliferative diabetic retinopathy Grade 4: proliferative diabetic retinopathy
The same day as dilated ophthalmic examination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università degli Studi di Brescia

Collaborators

Luisa Delcassi
Nausica Ghilardi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

June 24, 2014

First Submitted That Met QC Criteria

June 26, 2014

First Posted (Estimate)

June 30, 2014

Study Record Updates

Last Update Posted (Estimate)

June 30, 2014

Last Update Submitted That Met QC Criteria

June 26, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMART001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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