NCT03310788

Brief 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).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

October 2, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

October 3, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 16, 2017

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2022

Completed
Last Updated

May 12, 2021

Status Verified

May 1, 2021

Enrollment Period

4.5 years

First QC Date

October 2, 2017

Last Update Submit

May 11, 2021

Conditions

Glaucoma Open-Angle PrimaryPseudo Exfoliation Syndrome

Keywords

IOP fluctuationsiCare HomeSLTself-tonometry

Outcome Measures

Primary Outcomes (1)

  • Lowering of IOP fluctuations after SLT

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

    2 months

Secondary Outcomes (1)

  • Lowering of IOP level after SLT

    2 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • POAG
  • PXG

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Erik Eye Hospital

Stockholm, 11282, Sweden

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-AngleExfoliation Syndrome

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye DiseasesIris DiseasesUveal Diseases

Study Officials

  • Enping Chen, MD Ph D

    St. Erik Eye Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Enping Chen, MD PhD

CONTACT

004686720000enping.chen@sll.se

Laurence Quérat, M Sc

CONTACT

004686723240laurence.querat@sll.se

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD Ph D

Study Record Dates

First Submitted

October 2, 2017

First Posted

October 16, 2017

Study Start

October 3, 2017

Primary Completion

March 20, 2022

Study Completion

December 20, 2022

Last Updated

May 12, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)