iCare vs Tonopen vs Goldmann Applanation Post-vitrectomy Surgery

NCT ID: NCT01786954

Last Updated: 2016-05-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-09-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Intraocular Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Icare rebound tonometry

Intervention Type DEVICE

Tonopen applanation

Intervention Type DEVICE

Goldmann applanation

Intervention Type DEVICE

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.

Group Type EXPERIMENTAL

Icare rebound tonometry

Intervention Type DEVICE

Tonopen applanation

Intervention Type DEVICE

Goldmann applanation

Intervention Type DEVICE

Interventions

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Icare rebound tonometry

Intervention Type DEVICE

Tonopen applanation

Intervention Type DEVICE

Goldmann applanation

Intervention Type DEVICE

Other Intervention Names

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Tonopen Avia

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul Hahn, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University Eye Center

Locations

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Duke University Eye Center

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00036498

Identifier Type: -

Identifier Source: org_study_id

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