iCare vs Tonopen vs Goldmann Applanation Post-vitrectomy Surgery

Not Applicable

Completed

• Conditions: Intraocular Pressure
• Interventions: Device: Icare rebound tonometry; Device: Tonopen applanation; Device: Goldmann applanation

• Registration Number: NCT01786954
• Lead Sponsor: Duke University

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).

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 Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-02-06
• Study First Submitted QC: 2013-02-06
• Study First Posted: 2013-02-08
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2016-01
• Results First Submitted: 2016-01-20
• Results First Submitted QC: 2016-01-20
• Results First Posted: 2016-02-22
• Last Update Submitted: 2016-04-20
• Last Update Posted: 2016-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

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

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Exclusion Criteria

• individuals unable to give consent
• minors

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Icare then Tonopen then Goldmann	Goldmann applanation	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.
Icare then Goldmann then Tonopen	Icare rebound tonometry	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.
Icare then Goldmann then Tonopen	Tonopen applanation	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.
Icare then Tonopen then Goldmann	Icare rebound tonometry	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.
Icare then Goldmann then Tonopen	Goldmann applanation	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.
Icare then Tonopen then Goldmann	Tonopen applanation	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.

Primary Outcome Measures

Name	Time	Method
Measurement of Intraocular Pressure	postoperative day #1	The primary outcome is the measurement of intraocular pressure on postoperative day #1 following vitreoretinal surgery.

Secondary Outcome Measures

Name	Time	Method
Adverse Events	postoperative day #1	The secondary outcome is the onset of any adverse events related to measurement of intraocular pressure.

Trial Locations

Locations (1)

Duke University Eye Center; 🇺🇸 Durham, North Carolina, United States