NCT03445806

Brief Summary

The purpose of this study is to investigate how much trabeculectomy influences intraocular pressure (IOP) fluctuations measured with iCare Home rebound tonometry (RTHome) in patients with primary open-angle glaucoma (POAG) or pseudo-exfoliation glaucoma (PEX).

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 26, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

February 26, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2021

Completed
Last Updated

May 13, 2021

Status Verified

May 1, 2021

Enrollment Period

3.1 years

First QC Date

February 15, 2018

Last Update Submit

May 11, 2021

Conditions

Glaucoma, Open-AnglePseudo Exfoliation Syndrome

Keywords

IOP fluctuationsiCare HomeTrabeculectomyself-tonometry

Outcome Measures

Primary Outcomes (1)

  • Lowering of IOP levels after trabeculectomy

    Mean (SD) IOP pre- and post trabeculectomy

    2-3 months

Secondary Outcomes (1)

  • Lowering of IOP fluctuations after trabeculectomy

    2-3 months

Eligibility Criteria

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

Consecutive male and female patients, older than 18 y.o., at St Erik's Eye Hospital in Stockholm, Sweden, diagnosed with POAG or PXG and listed for a trabeculectomy.

You may qualify if:

  • POAG
  • PXG

You may not qualify if:

  • previous trabeculectomy
  • reduced hand and arm mobility (e. due to rheumatism)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Erik Eye Hospital

Stockholm, 11282, Sweden

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleExfoliation Syndrome

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye DiseasesIris DiseasesUveal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 15, 2018

First Posted

February 26, 2018

Study Start

February 26, 2018

Primary Completion

March 22, 2021

Study Completion

March 22, 2021

Last Updated

May 13, 2021

Record last verified: 2021-05

Locations

SE(1)