NCT01786954

Brief Summary

The purpose of the study is to compare the measurement of pressure inside the eye using three different FDA-approved devices (Icare, Tonopen, and Goldmann applanation).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2012

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 8, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

February 22, 2016

Completed
Last Updated

May 23, 2016

Status Verified

January 1, 2016

Enrollment Period

1.9 years

First QC Date

February 6, 2013

Results QC Date

January 20, 2016

Last Update Submit

April 20, 2016

Conditions

Intraocular Pressure

Keywords

vitreoretinal surgeryintraocular pressureapplanationreboundtonometry

Outcome Measures

Primary Outcomes (1)

  • Measurement of Intraocular Pressure

    The primary outcome is the measurement of intraocular pressure on postoperative day #1 following vitreoretinal surgery.

    postoperative day #1

Secondary Outcomes (1)

  • Adverse Events

    postoperative day #1

Study Arms (2)

Icare then Goldmann then Tonopen

EXPERIMENTAL

Enrolled patients will be subjected to intraocular pressure measurement using Icare rebound tonometry, Tonopen applanation, and Goldmann applanation. Patients receive Icare first and then are randomized to receive Tonopen followed by Goldmann OR Goldmann followed by Tonopen. This arm is Icare then Goldmann then Tonopen.

Device: Icare rebound tonometryDevice: Tonopen applanationDevice: Goldmann applanation

Icare then Tonopen then Goldmann

EXPERIMENTAL

Enrolled patients will be subjected to intraocular pressure measurement using Icare rebound tonometry, Tonopen applanation, and Goldmann applanation. Patients receive Icare first and then are randomized to receive Tonopen followed by Goldmann OR Goldmann followed by Tonopen. This arm is Icare then Tonopen then Goldmann.

Device: Icare rebound tonometryDevice: Tonopen applanationDevice: Goldmann applanation

Interventions

Icare rebound tonometryDEVICE
Icare then Goldmann then TonopenIcare then Tonopen then Goldmann
Tonopen applanationDEVICE
Also known as: Tonopen Avia
Icare then Goldmann then TonopenIcare then Tonopen then Goldmann
Goldmann applanationDEVICE
Icare then Goldmann then TonopenIcare then Tonopen then Goldmann

Eligibility Criteria

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

You may qualify if:

  • Duke Eye Center patients 18 years or older
  • capacity to give legally effective consent
  • scheduled to undergo vitreoretinal surgery

You may not qualify if:

  • individuals unable to give consent
  • minors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Eye Center

Durham, North Carolina, 27710, United States

Location

Results Point of Contact

Title
Dr Paul Hahn
Organization
Duke Eye Center
paul.s.hahn@duke.edu
919-684-5631

Study Officials

  • Paul Hahn, MD, PhD

    Duke University Eye Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2013

First Posted

February 8, 2013

Study Start

October 1, 2012

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

May 23, 2016

Results First Posted

February 22, 2016

Record last verified: 2016-01

Locations

US(1)