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

Completed

• Conditions: To Present the Clinical Outcomes of Diurnal IOP Monitoring and Determine Its Value in Our Clinical Practice

• Registration Number: NCT05400759
• Lead Sponsor: George Papanicolaou Hospital

Brief 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.

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 Timeline

• Study Start: 2007-11
• Primary Completion: 2014-12
• Study Completion: 2019-12
• Status Verified: 2022-05
• Study First Submitted: 2022-05-27
• Study First Submitted QC: 2022-05-27
• Last Update Submitted: 2022-05-27
• Study First Posted: 2022-06-02
• Last Update Posted: 2022-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1500

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.

Exclusion Criteria

Patients with missing data values for IOP

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diurnal IOP monitoring	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.