NCT02656836

Brief Summary

The overall objective of the study is to scope the self-management for self-monitoring glaucoma using home tonometry.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2015

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

November 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 15, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

February 5, 2020

Completed
Last Updated

February 5, 2020

Status Verified

January 1, 2020

Enrollment Period

5 months

First QC Date

January 11, 2016

Results QC Date

January 9, 2020

Last Update Submit

January 27, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Intraocular Pressure

    Intraocular pressure in mmHg units, obtained by tonometers. The investigators will determine agreement of intraocular pressure (IOP) measured using the home tonometer (patient) compared with IOP measured in the clinic.

    Two weeks

Secondary Outcomes (2)

  • Proportion of Patients Able and Willing to Use the Tonometer

    Two weeks

  • Proportion of Patients With an Adverse Event

    One month

Interventions

Evaluating intraocular pressure

Also known as: I-care tonometer

Eligibility Criteria

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

Adults with glaucoma attending clinic

You may qualify if:

  • Attending the glaucoma clinic for monitoring (for glaucoma or ocular hypertension)
  • Aged 18 years or over
  • Patient deemed able to monitor their IOP at home (by themselves or a helper)

You may not qualify if:

  • Not receiving IOP monitoring (for glaucoma or ocular hypertension)
  • Aged \<18 years
  • Patients deemed unable to monitor their IOP at home (and do not have someone who can help them) e.g., apparent physical or cognitive impairments that will not allow for the use of a home tonometer
  • Had surgery for their glaucoma (glaucoma surgery only; other surgeries included e.g., cataract surgery)
  • Patient has preexisting corneal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Experimental Medicine QUB

Belfast, Co.Antrim, BT12 6BA, United Kingdom

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Results Point of Contact

Title
Augusto Azuara-Blanco
Organization
Queen's University Belfast

Study Officials

  • Augusto Azuara-Blanco

    Queen's University, Belfast

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 11, 2016

First Posted

January 15, 2016

Study Start

November 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

February 5, 2020

Results First Posted

February 5, 2020

Record last verified: 2020-01

Locations