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

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03684174
• Other study ID #: 2018-00136
• Status: Completed
• Start date: April 1, 2017
• Est. completion date: October 31, 2017

Study information

• Verified date: September 2018
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: October 31, 2017
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma

Intervention

Device:
• Intraocular pressure measurement
Pressure tip or air puff is applied on eye

Locations

Country	Name	City	State
Switzerland	Augenpraxis Centerpassage	Wettingen	AG

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (4)

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. — View Citation

Jorge J, González-Méijome JM, Díaz-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. — View Citation

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. — View Citation

Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006 Mar;90(3):262-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of GAT with air tonometry Topcon CT1	Difference in mmHg between these two devices	7 months