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NCT02520674 Clinical Trial

Glaucoma Screening With Smartphone Ophthalmology

Glaucoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02520674
Other study ID # SMART002
Secondary ID
Status Completed
Phase N/A
First received August 3, 2015
Last updated August 11, 2015
Start date September 2014
Est. completion date August 2015

Study information
Verified date August 2015
Source Università degli Studi di Brescia
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the accuracy and reliability of smartphone ophthalmoscopy compared to slit-lamp biomicroscopy in glaucoma screening for potential community screening programs.

Recruitment information / eligibility
Status Completed
Enrollment 110
Est. completion date August 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- ocular hypertension

- glaucoma

Exclusion Criteria:

- substantial media opacity

- refractive error outside the range from -10.00 to +5.00 diopters

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Other:
• optic nerve head ophthalmoscopy
Patients underwent undilated smartphone ophthalmoscopy followed by undilated slit-lamp biomicroscopy for the grading of the vertical cup-to-disc ratio of the optic nerve head.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Università degli Studi di Brescia

Outcome
Type Measure Description Time frame Safety issue
Primary Vertical cup-to-disc ratio Up to 25 weeks from date of study initiation No
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