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TerminatedNCT03445806Updated May 13, 2021

IOP Monitoring After Trabeculectomy Using iCare Home

An observational study in Glaucoma, Open-Angle and Pseudo Exfoliation Syndrome, sponsored by St. Erik Eye Hospital. Terminated at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-13.

Sponsored by St. Erik Eye Hospital · Observational

Why this study was terminated
Difficulty recruiting patients
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 15 studies in Glaucoma, Open-Angle with a site in Sweden — 3 open to participants now, 5 under way, none of them phase 3. Glaucoma, Open-Angle · Sweden.

Started
2018
the only one that year
Observational
5 of 15
1 open now
Registered
7th of 15
by date
Lead sponsor
4 of 15
St. Erik Eye Hospital

Among the 15 studies in Glaucoma, Open-Angle with a site in Sweden, this one is the only one that started in 2018, is one of 5 observational ones, and was the 7th registered.

Glaucoma, Open-Angle

924 studies on the registry are indexed under Glaucoma, Open-Angle; 116 are open to participants now.

Browse Glaucoma, Open-Angle studies →

Open to participants now

3 of the 15 studies in Glaucoma, Open-Angle with a site in Sweden are open now. Recruiting first, the newest first:

All 3 open studies →

A study can be open while its sites in Sweden have not opened yet or have stopped. Only those recruiting at a site in Sweden →

Who these studies take

Of the 83 Glaucoma, Open-Angle studies recruiting now, 64 (77%) set no upper age limit and 5 (6%) stop at 75 or younger; 5 take children under 18; 11 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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).

Read the detailed description

Fifty glaucoma patients (POAG and PEX) planned for trabeculectomy will be recruited.

At baseline, patients will be trained to use the iCare Home tonometer (RTHome), a handheld device based on rebound tonometry and designed for patients to use at home. After the training session and when patients feel confident, a measurement will be recorded. At the same visit, a new measurement will be obtained by the study staff, an optometrist or a nurse, using the same device. No IOP values will be visible for the examiner at that point. A single IOP measurement will be obtained by the same study staff using Goldmann applanation tonometry (GAT). Patients will come for a second visit where new measurements will be made in the same way as at baseline.

In between visits, patients will borrow the iCare Home tonometer to measure their IOP at 06 and 10 am, and at 2, 6 and 10 pm during three consecutive days to obtain an IOP curve.

Two-three months after trabeculectomy, a new IOP curve will be obtained following the same procedure as pre-operatively. There will be no restrictions in patients' daily activities regarding diet, physical activity or slee. If patients use any eyedrops, they will continue to use them as prescribed.

03

Conditions studied

  • Glaucoma, Open-Angle
  • Pseudo Exfoliation Syndrome

Keywords

  • IOP fluctuations
  • iCare Home
  • Trabeculectomy
  • self-tonometry
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability 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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • POAG
  • PXG

Exclusion criteria

Exclusion Criteria:

  • previous trabeculectomy
  • reduced hand and arm mobility (e. due to rheumatism)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Lowering of IOP levels after trabeculectomy

    Mean (SD) IOP pre- and post trabeculectomy

    Time frame: 2-3 months

Secondary outcomes

  1. Lowering of IOP fluctuations after trabeculectomy

    Mean (SD) IOP range pre- and post trabeculectomy

    Time frame: 2-3 months

07

Study locations

1 site
  • St Erik Eye Hospital
    Stockholm, 11282, Sweden
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2018 to primary completion in Mar 2021, 36 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 15, 2018
First posted
Feb 26, 2018
StartActual
Feb 26, 2018
Primary completionActual
Mar 22, 2021
CompletionActual
Mar 22, 2021
Last update
May 13, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 13, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03445806
Lead sponsor
St. Erik Eye Hospital
Responsible party
Enping Chen (Principal Investigator, St. Erik Eye Hospital) — Principal investigator
First posted
Feb 26, 2018
Start date
Feb 26, 2018
Primary completion
Mar 22, 2021
Completion
Mar 22, 2021
Last update
May 13, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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