NCT02520674

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 13, 2015

Completed
Last Updated

August 13, 2015

Status Verified

August 1, 2015

Enrollment Period

9 months

First QC Date

August 3, 2015

Last Update Submit

August 11, 2015

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

  • Vertical cup-to-disc ratio

    Up to 25 weeks from date of study initiation

Study Arms (1)

Glaucoma and Ocular Hypertension

OTHER

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

Other: optic nerve head ophthalmoscopy

Interventions

optic nerve head ophthalmoscopyOTHER

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.

Glaucoma and Ocular Hypertension

Eligibility Criteria

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

You may qualify if:

  • ocular hypertension
  • glaucoma

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD Candidate

Study Record Dates

First Submitted

August 3, 2015

First Posted

August 13, 2015

Study Start

September 1, 2014

Primary Completion

June 1, 2015

Study Completion

August 1, 2015

Last Updated

August 13, 2015

Record last verified: 2015-08