- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02520674
Glaucoma Screening With Smartphone Ophthalmology
August 11, 2015 updated by: Andrea Russo, Università degli Studi di Brescia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
110
Phase
- Not Applicable
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:
- ocular hypertension
- glaucoma
Exclusion Criteria:
- substantial media opacity
- refractive error outside the range from -10.00 to +5.00 diopters
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
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Glaucoma and Ocular Hypertension
Patients to be examined with both smartphone ophthalmoscopy and slit-lamp biomicroscopy.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Vertical cup-to-disc ratio
Time Frame: Up to 25 weeks from date of study initiation
|
Up to 25 weeks from date of study initiation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
September 1, 2014
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
August 3, 2015
First Submitted That Met QC Criteria
August 11, 2015
First Posted (Estimate)
August 13, 2015
Study Record Updates
Last Update Posted (Estimate)
August 13, 2015
Last Update Submitted That Met QC Criteria
August 11, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SMART002
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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