NCT02837536

Brief Summary

The goal of this study is to evaluate the agreement between intraocular pressure (IOP) measurements taken by iCare, held in both vertical and horizontal positions. In addition, iCare measurements will be compared against pneumotonometry measurements to assess for accuracy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

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

June 23, 2016

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 8, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 19, 2016

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2016

Completed
Last Updated

March 8, 2017

Status Verified

March 1, 2017

Enrollment Period

27 days

First QC Date

July 8, 2016

Last Update Submit

March 6, 2017

Conditions

Intraocular Pressure

Outcome Measures

Primary Outcomes (3)

  • IOP taken by iCare - horizontal

    1 Day

  • IOP taken by iCare - vertical

    1 Day

  • IOP taken by pneumatonometer

    1 Day

Study Arms (2)

Horizontal iCare

ACTIVE COMPARATOR

In the horizontal iCare arm, these patients were randomized to have their IOP measured with the iCare tonometer held in the horizontal position first and then their IOP measured with the iCare tonometer held in the vertical position.

Other: Horizontal iCareOther: Vertical iCare

Vertical iCare

ACTIVE COMPARATOR

In the vertical iCare arm, these patients were randomized to have their IOP measured with the iCare tonometer held in the vertical position first and then their IOP measured with the iCare tonometer held in the horizontal position.

Other: Horizontal iCareOther: Vertical iCare

Interventions

Horizontal iCareOTHER

IOP of the right eye will be measured using the iCare tonometer held in the horizontal position first and then in the vertical position.

Horizontal iCareVertical iCare
Vertical iCareOTHER

IOP of the right eye will be measured using the iCare tonometer held in the vertical position first and then in the horizontal position.

Horizontal iCareVertical iCare

Eligibility Criteria

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

You may qualify if:

  • years of age or older
  • Must be able to understand and sign and informed consent form that has been approved by an Institutional Review Board/Ethics Committee

You may not qualify if:

  • Evidence of corneal epithelial defects or pathology affecting corneal rigidity
  • Use of topical ophthalmic medications (except for artificial tears)
  • History or corneal surgeries
  • Any condition that would prevent or inhibit intraocular pressure measurements using iCare or pneumotonometry
  • Evidence of ocular infection 30 days prior to enrollment
  • Allergy to proparacaine or latex

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robert Cizik Eye Clinic

Houston, Texas, 77030, United States

Location

Study Officials

  • Robert M. Feldman, M.D.

    Robert Cizik Eye Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

July 8, 2016

First Posted

July 19, 2016

Study Start

June 23, 2016

Primary Completion

July 20, 2016

Study Completion

December 23, 2016

Last Updated

March 8, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)