NCT03684174

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2017

Shorter than P25 for all trials

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

April 1, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 25, 2018

Completed
Last Updated

September 25, 2018

Status Verified

September 1, 2018

Enrollment Period

7 months

First QC Date

September 17, 2018

Last Update Submit

September 24, 2018

Conditions

Keywords

Tonometry

Outcome Measures

Primary Outcomes (1)

  • Comparison of GAT with air tonometry Topcon CT1

    Difference in mmHg between these two devices

    7 months

Interventions

Pressure tip or air puff is applied on eye

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

healthy volunteers

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Augenpraxis Centerpassage

Wettingen, Canton of Aargau, 5430, Switzerland

Location

Related 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. doi: 10.1001/archopht.120.6.714.

    PMID: 12049575BACKGROUND
  • 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.

    PMID: 14622352BACKGROUND
  • 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.

    PMID: 12523884BACKGROUND
  • 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.

    PMID: 16488940BACKGROUND

MeSH Terms

Conditions

Glaucoma

Interventions

Tonometry, Ocular

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, OphthalmologicalDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Pascal B Knecht, MD PD

    University of Zurich

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2018

First Posted

September 25, 2018

Study Start

April 1, 2017

Primary Completion

October 31, 2017

Study Completion

October 31, 2017

Last Updated

September 25, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations