To Present the Clinical Outcomes of Diurnal IOP Monitoring and Determine Its Value in Our Clinical PracticeNCT05400759
Clinical Outcomes of the Implementation of Diurnal IOP Curve to 1500 Patients - A Cohort Study.
An observational study of To Present the Clinical Outcomes of Diurnal IOP Monitoring and Determine Its Value in Our Clinical Practice, run by George Papanicolaou Hospital.
Trial summary
To present the clinical outcomes of diurnal IOP monitoring and determine its value in our clinical practice.We reviewed the records of 1500 patients (glaucoma suspects or glaucoma patients), who were admitted for diurnal curve during almost 12 years. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- To Present the Clinical Outcomes of Diurnal IOP Monitoring and Determine Its Value in Our Clinical Practice
- What is being tested?
- IOP monitoring data
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- Nov 2007to Dec 2019
- 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 to 85 years
- All sexes
- Adult, Older adult
Study population: The patients were retrieved from the eye clinic database. The records of all 1500 patients were retrospectively reviewed. We included the last 1500 patients who had undergone diurnal IOP monitoring in the clinic until the conduct of the study. All of them were hospitalized between November 2007 and December 2019, at the Eye Clinic of General Hospital "George Papanikolaou" in Thessaloniki, Greece.
Inclusion Criteria: IOP diurnal curve consisted of glaucoma patients with intraocular pressure higher than target pressure despite referred previously sufficient therapy and also patients with equal or lower than target pressure, but with disease progression. There were also included patients with advanced glaucoma with visual field defects on the visual field testing, as well as patients with normal tension glaucoma and labile secondary glaucomas (exfoliative, pigmentary and chronic angle closure glaucoma), for whom close monitoring and therapy reconsidering was judged appropriate.Glaucoma suspects, demonstrating findings consistent with increased risk for glaucoma development, were included.
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Exclusion Criteria: Patients with missing data values for IOP
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About this study
To present the clinical outcomes of diurnal IOP monitoring and determine its value in our clinical practice.We reviewed the records of 1500 patients (glaucoma suspects or glaucoma patients), who were admitted for diurnal curve during almost 12 years.
Read the detailed description
We reviewed the records of 1500 patients, who were admitted for diurnal curve during almost 12 years. All patients were hospitalized because their within office-hours exams were considered inadequate and inconclusive for decision-making
744 patients needed change of treatment. 121 patients were programmed for interventional therapy (laser or surgery). 68 patients were declassified, as overdiagnosed and overtreated. In 250 patients hidden adherence problem revealed. In 720 patients peak IOP occurred out of office hours.
- Being tested
- IOP monitoring data
- Keywords
- Tonometric curve, diurnal IOP, IOP phasing, IOP monitoring, glaucoma, glaucoma suspects, IOP peaks, hypertension, compliance, adherence,
- Medical subject headings
- Glaucoma, Hypertension, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IOP monitoring dataOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Diurnal IOP monitoring
This analysis provides a "real life' account of IOP in a large number of glaucoma suspects and patients. Our results demonstrate the potential for significant additional information, being obtained from diurnal IOP monitoring, in clinical practice.
Measured: 12 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study startNov 2007
- Primary completionDec 2014
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Present the Clinical Outcomes of Diurnal IOP Monitoring and Determine Its Value in Our Clinical PracticeStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Papanicolaou Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diamantis Almaliotis, George Papanicolaou Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05400759
- Sponsor's protocol ID
- GeorgePH 1500 IOP
- Status last verified
- May 2022
- First submitted
- 27 May 2022
- Last updated
- 2 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of the Implementation of Diurnal IOP Curve to 1500 Patients - A Cohort Study.
- ClinicalTrials.gov ID
- NCT05400759
- Acronym / sponsor ID
- GeorgePH 1500 IOP
- Keywords
- Tonometric curve, diurnal IOP, IOP phasing, IOP monitoring, glaucoma, glaucoma suspects, IOP peaks, hypertension, compliance, adherence,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- George Papanicolaou HospitalUniversity, hospital or other
- Study start
- Nov 2007 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 2 Jun 2022 (actual)
- 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.
To present the clinical outcomes of diurnal IOP monitoring and determine its value in our clinical practice.We reviewed the records of 1500 patients (glaucoma suspects or glaucoma patients), who were admitted for diurnal curve during almost 12 years.
Detailed description
We reviewed the records of 1500 patients, who were admitted for diurnal curve during almost 12 years. All patients were hospitalized because their within office-hours exams were considered inadequate and inconclusive for decision-making
744 patients needed change of treatment. 121 patients were programmed for interventional therapy (laser or surgery). 68 patients were declassified, as overdiagnosed and overtreated. In 250 patients hidden adherence problem revealed. In 720 patients peak IOP occurred out of office hours.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The patients were retrieved from the eye clinic database. The records of all 1500 patients were retrospectively reviewed. We included the last 1500 patients who had undergone diurnal IOP monitoring in the clinic until the conduct of the study. All of them were hospitalized between November 2007 and December 2019, at the Eye Clinic of General Hospital "George Papanikolaou" in Thessaloniki, Greece.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IOP monitoring data | Other | – |
Primary outcome
Diurnal IOP monitoring
Time frame: 12 years
This analysis provides a "real life' account of IOP in a large number of glaucoma suspects and patients. Our results demonstrate the potential for significant additional information, being obtained from diurnal IOP monitoring, in clinical practice.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of To Present the Clinical Outcomes of Diurnal IOP Monitoring and Determine Its Value in Our Clinical Practice, run by George Papanicolaou Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Diurnal IOP monitoring (time frame: 12 years). 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 2 Jun 2022.