Clinical Outcomes of the Implementation of Diurnal IOP Curve to 1500 Patients - A Cohort 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.

Study Overview

• Status: Completed
• Conditions: To Present the Clinical Outcomes of Diurnal IOP Monitoring and Determine Its Value in Our Clinical Practice
• Intervention / Treatment: Other: IOP monitoring data

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 Type: Observational
• Enrollment (Actual): 1500

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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.

Description

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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Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 years

Collaborators and Investigators

• Sponsor: George Papanicolaou Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2007
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: May 27, 2022
• First Submitted That Met QC Criteria: May 27, 2022
• First Posted (Actual): June 2, 2022

Study Record Updates

• Last Update Posted (Actual): June 2, 2022
• Last Update Submitted That Met QC Criteria: May 27, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Tonometric curve, diurnal IOP, IOP phasing, IOP monitoring, glaucoma, glaucoma suspects, IOP peaks, hypertension, compliance, adherence,
• Other Study ID Numbers: GeorgePH 1500 IOP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No