iCare vs Tonopen vs Goldmann Applanation Post-vitrectomy Surgery

April 20, 2016 updated by: Duke University

A Comparative Study of Icare Rebound Tonometry With Other Tonometry Modalities in Patients Following Vitreoretinal Surgery.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The three above devices will be used to measure intraocular pressure in patients one day following vitreoretinal surgery. The underlying reason for surgery is not being considered in this study. The measured pressures will be compared across devices in eyes filled with fluid, gas, and silicone oil.

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Eye Center

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:

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

Exclusion Criteria:

  • individuals unable to give consent
  • minors

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: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Icare then Goldmann then Tonopen
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 tonometry
Device: Tonopen applanation
Other Names:
  • Tonopen Avia
Device: Goldmann applanation
Experimental: Icare then Tonopen then Goldmann
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 tonometry
Device: Tonopen applanation
Other Names:
  • Tonopen Avia
Device: Goldmann applanation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of Intraocular Pressure
Time Frame: postoperative day #1
The primary outcome is the measurement of intraocular pressure on postoperative day #1 following vitreoretinal surgery.
postoperative day #1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: postoperative day #1
The secondary outcome is the onset of any adverse events related to measurement of intraocular pressure.
postoperative day #1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Paul Hahn, MD, PhD, Duke University Eye Center

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

October 1, 2012

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

February 6, 2013

First Submitted That Met QC Criteria

February 6, 2013

First Posted (Estimate)

February 8, 2013

Study Record Updates

Last Update Posted (Estimate)

May 23, 2016

Last Update Submitted That Met QC Criteria

April 20, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Pro00036498

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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