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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT02379208
Other study ID # T58/2012
Secondary ID
Status Enrolling by invitation
Phase N/A
First received February 3, 2015
Last updated February 26, 2015
Start date April 2015
Est. completion date May 2020

Study information

Verified date February 2015
Source Turku University Hospital
Contact n/a
Is FDA regulated No
Health authority Finland: Ethics CommitteeFinland: Data Protection BoardFinland: Valvira - National Supervisory Authority for Welfare and Health
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 60
Est. completion date May 2020
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Recently diagnosed open angle glaucoma

Exclusion Criteria:

- Significant visual impairment due to another disease (e.g. diabetic retinopathy or maculopathy, cataract, visual field defect after stroke)

- Inability to perform perimetry reliably

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Finland Turku University Central Hospital Turku

Sponsors (1)

Lead Sponsor Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in mean defect in Octopus perimetry Baseline, 2, 4, 8, 12, 16, 20, 22, 24 months No
Secondary Change in VF-7- instrument score Change in quality of life 2, 12, 24 months No
Secondary Change in 15D-instrument score Change in quality of life 2, 12, 24 months No
Secondary Differences in visual field defects between Octopus, frequency doubling technology, RareBit-perimeters 2, 12, 24 months No
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