Non-Contact Air Tonometry (Topcon CT-1®) Versus Goldmann

Non-Contact Air Tonometry (Topcon CT-1®) Versus Goldmann Applanation Tonometry: a Device Comparison Study

In this prospective device comparison study with 58 healthy eyes, the Topcon CT-1® showed statistically significant elevated intraocular pressure measurements compared to the gold standard Goldmann application tonometry.

Study Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: Device: Intraocular pressure measurement

Detailed Description

Introduction:

Intraocular pressure (IOP) measurement is crucial in glaucoma diagnosis and treatment. We compared a non-contact air tonometer (Topcon CT-1®) with the gold standard Goldmann Applikation tonometer (GAT).

Methods:

In this prospective, mono centric device comparison study, only healthy eyes were enrolled. IOP was measured three times with the Topcon CT-1® followed by three times GAT. Mean IOP was calculated and compared with a paired t-test, a linear regression and a Bland-Altman analysis.

• Study Type: Observational
• Enrollment (Actual): 58

Contacts and Locations

Study Locations

• Switzerland
  • AG
    • Wettingen, AG, Switzerland, 5430
      • Augenpraxis Centerpassage

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

healthy volunteers

Description

Inclusion Criteria:

Healthy volunteers who agreed to be included in the study and were able to comply with the measurement procedures

Exclusion criteria were cor-neal abnormalities (such as oedema, scars or dystrophies, astigmatism,hyperopia or myopia > 3 dioptres), a history of ocular surgery or recent(<47 weeks) ocular disorder.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of GAT with air tonometry Topcon CT1	Difference in mmHg between these two devices	7 months

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Study Chair: Pascal B Knecht, MD PD, University of Zurich

Publications and helpful links

General Publications

• Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006 Mar;90(3):262-7. doi: 10.1136/bjo.2005.081224.
• Gordon MO, Beiser JA, Brandt JD, Heuer DK, Higginbotham EJ, Johnson CA, Keltner JL, Miller JP, Parrish RK 2nd, Wilson MR, Kass MA. The Ocular Hypertension Treatment Study: baseline factors that predict the onset of primary open-angle glaucoma. Arch Ophthalmol. 2002 Jun;120(6):714-20; discussion 829-30. doi: 10.1001/archopht.120.6.714.
• Jorge J, Gonzalez-Meijome JM, Diaz-Rey JA, Almeida JB, Ribeiro P, Parafita MA. Clinical performance of non-contact tonometry by Reichert AT550 in glaucomatous patients. Ophthalmic Physiol Opt. 2003 Nov;23(6):503-6. doi: 10.1046/j.1475-1313.2003.00139.x.
• Leske MC, Heijl A, Hussein M, Bengtsson B, Hyman L, Komaroff E; Early Manifest Glaucoma Trial Group. Factors for glaucoma progression and the effect of treatment: the early manifest glaucoma trial. Arch Ophthalmol. 2003 Jan;121(1):48-56. doi: 10.1001/archopht.121.1.48.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2017
• Primary Completion (ACTUAL): October 31, 2017
• Study Completion (ACTUAL): October 31, 2017

Study Registration Dates

• First Submitted: September 17, 2018
• First Submitted That Met QC Criteria: September 24, 2018
• First Posted (ACTUAL): September 25, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 25, 2018
• Last Update Submitted That Met QC Criteria: September 24, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Tonometry
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: 2018-00136

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No