NCT02624427

Brief Summary

The study is investigating Intra ocular pressure (IOP) by Goldmann Applanation Tonometry, Dynamic Contour Tonometry, and the Corvis ST tonometer.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
109

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2015

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

First Submitted

Initial submission to the registry

November 27, 2015

Completed
4 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 8, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

June 21, 2017

Status Verified

June 1, 2017

Enrollment Period

8 months

First QC Date

November 27, 2015

Last Update Submit

June 20, 2017

Conditions

Glaucoma

Keywords

GlaucomaIntraocular Pressure

Outcome Measures

Primary Outcomes (1)

  • Delta IOP

    IOP difference of Goldmann tonometer and Dynamic Contour tonometer

    baseline

Secondary Outcomes (1)

  • Correlation of IOP difference of Goldmann tonometer and Dynamic Contour tonometer with biomechanical corneal properties measured by Corvis ST tonometer

    baseline

Study Arms (2)

Glaucoma Eyes

EXPERIMENTAL

Measurement of intraocular pressure (IOP)

Device: Measurement of intraocular pressure (IOP)

Healthy Eyes

ACTIVE COMPARATOR

age-matched healthy eyes as controls will undergo Measurement of intraocular pressure (IOP)

Device: Measurement of intraocular pressure (IOP)

Interventions

Measurement of intraocular pressure (IOP)DEVICE

Measurement of IOP with the following devices: (1) Goldmann tonometer, (2) Dynamic Contour tonometer, and (3) Corvis ST tonometer

Glaucoma EyesHealthy Eyes

Eligibility Criteria

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

You may qualify if:

  • diagnosis of glaucoma
  • years old or older with no upper limit

You may not qualify if:

  • IOP lowering surgery within the last 3 weeks
  • any corneal surgery in the past
  • bad fixation
  • insufficient measurement quality with any of the study devices
  • no diagnosis of glaucoma
  • years old or older with no upper limit
  • any diagnosis of glaucoma
  • IOP lowering surgery within the last 3 weeks
  • any corneal surgery in the past
  • bad fixation
  • insufficient measurement quality with any of the study devices

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Jens Funk, MD PhD

    UniversityHospital of Zurich, Zurich, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2015

First Posted

December 8, 2015

Study Start

December 1, 2015

Primary Completion

August 1, 2016

Study Completion

November 1, 2016

Last Updated

June 21, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share