ClinicalTrials.gg
Status unknownNCT03310788Updated May 12, 2021

Monitoring of the IOP After SLT Using iCare Home

An observational study in Glaucoma Open-Angle Primary and Pseudo Exfoliation Syndrome, sponsored by St. Erik Eye Hospital. Status unknown at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-12.

Sponsored by St. Erik Eye Hospital · Observational

The sponsor has not verified this record recently (last verified May 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
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
2017
the only one that year
Observational
5 of 15
1 open now
Registered
6th 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 2017, is one of 5 observational ones, and was the 6th 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.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 15 studies in Glaucoma, Open-Angle with a site in Sweden, or all of them as a file.
02

Study summary

The purpose of this study is to investigate how much selective trabeculoplasty (SLT) 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

Sixty glaucoma patients (POAG and PEX) planned for SLT will be recruited.

At baseline, patients will be trained to use the iCare Home tonometer, 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. Thereafter, 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. Thereafter, a single IOP measurement will be obtained by the same study staff using Goldmann applanation tonometry (GAT). Patients will then borrow the iCare Home tonometer to meaure their IOP at 06 and 10 am, and at 2, 6 and 10 pm during three consecutive days to obtain an IOP curve. Patients will come for a second visit where new measurements will be made in the same way as at baseline.

Two months after SLT, a new IOP curve will be obtained following the same procedure as pre-operatively. Patients' daily activities (diet, motion or sleeping habits) will not be controlled.

03

Conditions studied

  • Glaucoma Open-Angle Primary
  • Pseudo Exfoliation Syndrome

Keywords

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

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-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 SLT.

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 SLT
  • reduced hand and arm mobility (e.g. due to rheumatism)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Lowering of IOP fluctuations after SLT

    The amplitude of the IOP fluctuations pre- and post SLT will be compared

    Time frame: 2 months

Secondary outcomes

  1. Lowering of IOP level after SLT

    Mean IOP pre- and post SLT

    Time frame: 2 months

07

Study locations

1 of 1 sites recruiting
  • St Erik Eye Hospital
    Stockholm, 11282, Sweden
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2017 (actual). Primary completion is estimated for Mar 2022, 53 months after the start.

Of 53 observational studies under Glaucoma, Open-Angle, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12. This study's planned 53 months is above that.

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

Registered
Oct 2, 2017
First posted
Oct 16, 2017
StartActual
Oct 3, 2017
Primary completionEst.
Mar 20, 2022
CompletionEst.
Dec 20, 2022
Last update
May 12, 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 12, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03310788
Lead sponsor
St. Erik Eye Hospital
Responsible party
Enping Chen (MD Ph D, St. Erik Eye Hospital) — Principal investigator
First posted
Oct 16, 2017
Start date
Oct 3, 2017
Primary completion
Mar 20, 2022 (estimated)
Completion
Dec 20, 2022 (estimated)
Last update
May 12, 2021

Study contacts

Enping Chen, MD PhD
Contact
enping.chen@sll.se
004686720000
Laurence Quérat, M Sc
Contact
laurence.querat@sll.se
004686723240
Enping Chen, MD Ph D
principal investigator · St. Erik Eye Hospital

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 status unknown, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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