Non-Contact Air Tonometry (Topcon CT-1®) Versus Goldmann | NCT03684174

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

NCT03684174

Sponsor

University of Zurich

Status

Completed

Last Update Posted

Sep 25, 2018Actual

Enrollment

58Actual

Phase

Not provided

Conditions

Glaucoma

Interventions

Intraocular pressure measurement

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2017Actual

Primary Completion Date

Oct 31, 2017Actual

Completion Date

Oct 31, 2017Actual

First Submitted Date

Sep 17, 2018

First Submission Date that Met QC Criteria

Sep 24, 2018

First Posted Date

Sep 25, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 24, 2018

Last Update Posted Date

Sep 25, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

58Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intraocular pressure measurement	Device	Pressure tip or air puff is applied on eye

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

healthy volunteers

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pascal B Knecht, MD PD	University of Zurich	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Augenpraxis Centerpassage		Wettingen	Canton of Aargau	5430	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12049575	Background	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.
14622352

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases

ID	Term
D003941	Diagnostic Techniques, Ophthalmological
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis