NCT02177747

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 30, 2014

Completed
Last Updated

June 30, 2014

Status Verified

June 1, 2014

Enrollment Period

5 months

First QC Date

June 24, 2014

Last Update Submit

June 26, 2014

Conditions

Diabetic Retinopathy Grading

Outcome Measures

Primary Outcomes (1)

  • Diabetic retinopathy grading

    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

Study Arms (1)

Diabet patients

EXPERIMENTAL

Smartphone ophthalmoscopy followed by traditional slit-lamp dilated ophthalmoscopy

Other: Ophthalmoscopy conducted using a smartphone equipped with a compact addonDevice: Smartphone

Interventions

Ophthalmoscopy conducted using a smartphone equipped with a compact addonOTHER
Diabet patients
SmartphoneDEVICE
Diabet patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • significant optic media opacities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spedali Civili di Brescia

Brescia, BS, 25123, Italy

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD Researcher

Study Record Dates

First Submitted

June 24, 2014

First Posted

June 30, 2014

Study Start

November 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

June 30, 2014

Record last verified: 2014-06

Locations

IT(1)