Assessment of a New Goldmann Applanation Tonometer | NCT00555763

Studies
Assessment of a New Goldmann Applanation Tonometer

NCT00555763

Sponsor

Insel Gruppe AG, University Hospital Bern

Status

Completed

Last Update Posted

Jul 14, 2011Estimated

Enrollment

157Actual

Phase

Phase 3

Conditions

Intraocular Pressure

Interventions

Tonometry

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

ID	Type	Description	Link
162/07

Status Module

Record Verification Date

Jul 2011

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

Aug 2007

Primary Completion Date

May 2008Actual

Completion Date

Jul 2008Actual

First Submitted Date

Nov 8, 2007

First Submission Date that Met QC Criteria

Nov 8, 2007

First Posted Date

Nov 9, 2007Estimated

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

Jul 13, 2011

Last Update Posted Date

Jul 14, 2011Estimated

Name	Class
Haag-Streit AG	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The classic Goldmann applanation tonometer has been further developed. The applanation principle has been retained, while the internal force transmission and the pressure gauging have been optimized, and the display of results digitized.

The purpose of the study is to compare the standard Goldmann applanation tonometer AT900 with the new version of the device, and to test the reliability and reproducibility of measurements, as well as its safety.

Detailed Description

Patients at the Department of Ophthalmology, University of Bern, will be included after informed consent. The study has been approved by the local ethical committee. Routine ophthalmologic examination will be performed and inclusion criteria evaluated. Measurements will be taken with the two tonometers in random order. Prior to pressure measurement, central corneal thickness will be measured with a non-contact method (Optical Low Coherence Reflectometry, OLCR pachymeter, Haag-Streit, Koeniz, Switzerland).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

157Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator		Device: Tonometry

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tonometry	Device	Tonometry : measurement of intraocular pressure with an applanation tonometer	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intraocular Pressure in mmHG		single event

Secondary Outcomes

Measure	Description	Time Frame
safety of measurement		single event, up to one week post measurement

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patient willing to participate and signed informed consent

Exclusion Criteria:

patient under 18 y of age
patient pregnant
not steady fixation, nystagm
corneal scars or corneal disease
astigmatism higher than 2.5 diopters
corneal surgery in the past
microphthalmos or buphthalmos
contact lens wear
dry eye syndrome
blepharospasm
active inflammation of conjunctiva, cornea or uvea
known allergy to topical oxybuprocain for topical anaesthesia
known allergy to fluorescein solution (used for applanation tonometry)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Milko E Iliev, MD	University Eye Hospital Berne	Principal Investigator
Sebastian Wolf, MD	University Eye Hospital Berne	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Eye Hospital Berne		Bern	Canton of Bern	3010	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
14443098	Background	SCHMIDT TA. The clinical application of the Goldmann applanation tonometer. Am J Ophthalmol. 1960 May;49:967-78. doi: 10.1016/0002-9394(60)91818-3. No abstract available.
13706587	Background	GOLDMANN H, SCHMIDT T. [Further contribution to applanation tonometry]. Ophthalmologica. 1961 Jun;141:441-56. doi: 10.1159/000304099. No abstract available. German.