iCare vs Tonopen vs Goldmann Applanation Post-vitrectomy Surgery

Intraocular Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01786954
• Other study ID #: Pro00036498
• Status: Completed
• Phase: N/A
• First received: February 6, 2013
• Last updated: January 20, 2016
• Start date: October 2012
• Est. completion date: September 2014

Study information

• Verified date: January 2016
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Intraocular Pressure

Intervention

Device:
• Icare rebound tonometry

• Tonopen applanation

• Goldmann applanation

Locations

Country	Name	City	State
United States	Duke University Eye Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of Intraocular Pressure	The primary outcome is the measurement of intraocular pressure on postoperative day #1 following vitreoretinal surgery.	postoperative day #1	No
Secondary	Adverse Events	The secondary outcome is the onset of any adverse events related to measurement of intraocular pressure.	postoperative day #1	Yes