Glaucoma, Open-AngleNCT02379208
Evaluation of Rate of Progression With Perimetry in Newly Diagnosed Open Angle Glaucoma
An observational study of Glaucoma, Open-Angle and Ocular Hypertension, run by Turku University Hospital at 1 site in Finland.
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?… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Open-Angle, Ocular Hypertension
- How many people
- 60 participants
- Where
- 1 siteFinland
- Study dates
- Apr 2015to May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred to Turku University Central Hospital for suspected or newly diagnosed open angle glaucoma
Who may be able to join
- Recently diagnosed open angle glaucoma
Who cannot join
- Significant visual impairment due to another disease (e.g. diabetic retinopathy or maculopathy, cataract, visual field defect after stroke)
- Inability to perform perimetry reliably
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Keywords
- Visual Field Tests, Ocular Hypertension, Glaucoma, Open-Angle, Quality of Life, Glaucoma progression, Early glaucoma, Frequency Doubling Technology (FDT), RareBit, Octopus 900 perimetry
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension, Glaucoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean defect in Octopus perimetry
Measured: Baseline, 2, 4, 8, 12, 16, 20, 22, 24 months
Secondary outcomes (3)
Change in VF-7- instrument score
Change in quality of life
Measured: 2, 12, 24 months
Change in 15D-instrument score
Change in quality of life
Measured: 2, 12, 24 months
Differences in visual field defects between Octopus, frequency doubling technology, RareBit-perimeters
Measured: 2, 12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2019 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Open-AngleStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Eija Vesti, Professor, Study director, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02379208
- Sponsor's protocol ID
- T58/2012
- Status last verified
- Feb 2015
- First submitted
- 3 Feb 2015
- Last updated
- 4 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Rate of Progression With Perimetry in Newly Diagnosed Open Angle Glaucoma
- ClinicalTrials.gov ID
- NCT02379208
- Acronym / sponsor ID
- T58/2012
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Keywords
- Visual Field Tests, Ocular Hypertension, Glaucoma, Open-Angle, Quality of Life, Glaucoma progression, Early glaucoma, Frequency Doubling Technology (FDT), RareBit
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- Apr 2015
- Primary completion
- Dec 2019 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 4 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to Turku University Central Hospital for suspected or newly diagnosed open angle glaucoma
Key inclusion criteria (1 listed)
- Recently diagnosed open angle glaucoma
Key exclusion criteria (2 listed)
- Significant visual impairment due to another disease (e.g. diabetic retinopathy or maculopathy, cataract, visual field defect after stroke)
- Inability to perform perimetry reliably
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in mean defect in Octopus perimetry
Time frame: Baseline, 2, 4, 8, 12, 16, 20, 22, 24 months
3 secondary outcomes
Change in VF-7- instrument score
Time frame: 2, 12, 24 months
Change in 15D-instrument score
Time frame: 2, 12, 24 months
Differences in visual field defects between Octopus, frequency doubling technology, RareBit-perimeters
Time frame: 2, 12, 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2015.
Related trials for Glaucoma, Open-Angle
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eija Vesti, Professor study director
University of Turku
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, Open-Angle and Ocular Hypertension, run by Turku University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean defect in Octopus perimetry (time frame: Baseline, 2, 4, 8, 12, 16, 20, 22, 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2015.