NCT02379208

Brief Summary

The purpose of this study is to evaluate rate of progression in newly diagnosed open angle glaucoma with different types of perimetry. Would it be possible to find the rapidly progressing individuals sooner by doing perimetry more often? Is there a difference between different types of perimetry in early glaucoma? What would be the optimal timing of perimetry in newly diagnosed glaucoma? In addition the quality of life in glaucoma patients will be evaluated with two types of questionnaires in three different time points. The enrolled patients will receive appropriate treatment according to glaucoma management guidelines.

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 Apr 2015

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

February 3, 2015

Completed
29 days until next milestone

First Posted

Study publicly available on registry

March 4, 2015

Completed
28 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

March 4, 2015

Status Verified

February 1, 2015

Enrollment Period

4.7 years

First QC Date

February 3, 2015

Last Update Submit

February 26, 2015

Conditions

Glaucoma, Open-AngleOcular Hypertension

Keywords

Visual Field TestsOcular HypertensionGlaucoma, Open-AngleQuality of LifeGlaucoma progressionEarly glaucomaFrequency Doubling Technology (FDT)RareBitOctopus 900 perimetry

Outcome Measures

Primary Outcomes (1)

  • Change in mean defect in Octopus perimetry

    Baseline, 2, 4, 8, 12, 16, 20, 22, 24 months

Secondary Outcomes (3)

  • Change in VF-7- instrument score

    2, 12, 24 months

  • Change in 15D-instrument score

    2, 12, 24 months

  • Differences in visual field defects between Octopus, frequency doubling technology, RareBit-perimeters

    2, 12, 24 months

Eligibility Criteria

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

Patients referred to Turku University Central Hospital for suspected or newly diagnosed open angle glaucoma

You may qualify if:

  • Recently diagnosed open angle glaucoma

You may not qualify if:

  • Significant visual impairment due to another disease (e.g. diabetic retinopathy or maculopathy, cataract, visual field defect after stroke)
  • Inability to perform perimetry reliably

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku University Central Hospital

Turku, 20521, Finland

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular HypertensionGlaucoma

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Eija Vesti, Professor

    University of Turku

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2015

First Posted

March 4, 2015

Study Start

April 1, 2015

Primary Completion

December 1, 2019

Study Completion

May 1, 2020

Last Updated

March 4, 2015

Record last verified: 2015-02

Locations

FI(1)