NCT00555763

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
157

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2007

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 9, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

July 14, 2011

Status Verified

July 1, 2011

Enrollment Period

9 months

First QC Date

November 8, 2007

Last Update Submit

July 13, 2011

Conditions

Intraocular Pressure

Keywords

Intraocular pressureGoldmann tonometryapplanation tonometryTonometry, Ocular

Outcome Measures

Primary Outcomes (1)

  • Intraocular Pressure in mmHG

    single event

Secondary Outcomes (1)

  • safety of measurement

    single event, up to one week post measurement

Study Arms (1)

1

ACTIVE COMPARATOR
Device: Tonometry

Interventions

TonometryDEVICE

Tonometry : measurement of intraocular pressure with an applanation tonometer

1

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient willing to participate and signed informed consent

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Eye Hospital Berne

Bern, Canton of Bern, 3010, Switzerland

Location

Related Publications (3)

  • 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.

    PMID: 14443098BACKGROUND

  • GOLDMANN H, SCHMIDT T. [Further contribution to applanation tonometry]. Ophthalmologica. 1961 Jun;141:441-56. doi: 10.1159/000304099. No abstract available. German.

    PMID: 13706587BACKGROUND

  • GOLDMANN H, SCHMIDT T. [Applanation tonometry]. Ophthalmologica. 1957 Oct;134(4):221-42. doi: 10.1159/000303213. No abstract available. German.

    PMID: 13484216BACKGROUND

MeSH Terms

Interventions

Manometry

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Milko E Iliev, MD

    University Eye Hospital Berne

    PRINCIPAL INVESTIGATOR

  • Sebastian Wolf, MD

    University Eye Hospital Berne

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 8, 2007

First Posted

November 9, 2007

Study Start

August 1, 2007

Primary Completion

May 1, 2008

Study Completion

July 1, 2008

Last Updated

July 14, 2011

Record last verified: 2011-07

Locations

CH(1)