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Glaucoma Screening With Smartphone Ophthalmology

Primary Purpose

Glaucoma

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
optic nerve head ophthalmoscopy
Sponsored by
Università degli Studi di Brescia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ocular hypertension
  • glaucoma

Exclusion Criteria:

  • substantial media opacity
  • refractive error outside the range from -10.00 to +5.00 diopters

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Glaucoma and Ocular Hypertension

    Arm Description

    Patients to be examined with both smartphone ophthalmoscopy and slit-lamp biomicroscopy.

    Outcomes

    Primary Outcome Measures

    Vertical cup-to-disc ratio

    Secondary Outcome Measures

    Full Information

    First Posted
    August 3, 2015
    Last Updated
    August 11, 2015
    Sponsor
    Università degli Studi di Brescia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02520674
    Brief Title
    Glaucoma Screening With Smartphone Ophthalmology
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2014 (undefined)
    Primary Completion Date
    June 2015 (Actual)
    Study Completion Date
    August 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Università degli Studi di Brescia

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glaucoma

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    Investigator
    Allocation
    N/A
    Enrollment
    110 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Glaucoma and Ocular Hypertension
    Arm Type
    Other
    Arm Description
    Patients to be examined with both smartphone ophthalmoscopy and slit-lamp biomicroscopy.
    Intervention Type
    Other
    Intervention Name(s)
    optic nerve head ophthalmoscopy
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Vertical cup-to-disc ratio
    Time Frame
    Up to 25 weeks from date of study initiation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ocular hypertension glaucoma Exclusion Criteria: substantial media opacity refractive error outside the range from -10.00 to +5.00 diopters

    12. IPD Sharing Statement

    Learn more about this trial

    Glaucoma Screening With Smartphone Ophthalmology

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