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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06227299
Other study ID # INTEGRAL
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date May 29, 2018
Est. completion date January 2030

Study information

Verified date January 2024
Source Swiss Glaucoma Research Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The aim of this study is to create a large-scale register of all glaucoma patients diagnosed, followed and treated in a large tertiary centre specialising in glaucoma, in order to analyse whether specific factors influence the progression of the disease or guide our choice of treatment. This should lead to a better understanding of the disease and the factors to be taken into account when choosing the best treatment option for each patient, leading to safer, more effective and patient-centred care.


Description:

Glaucoma encompasses a group of chronic diseases characterized by progressive retinal nerve fibre loss and a concomitant pattern of visual field damage, eventually leading to blindness. To date, it is still considered the first cause of irreversible blindness worldwide. In recent years, treatment options for glaucoma have soared, and ophthalmologists can resort to a wide selection of drops, laser procedures and surgical techniques to reduce intraocular pressure, and slow the progression of the disease. The choice of the technique, however, often depends on personal preferences and it is still unclear if a specific technique is more efficient or safe, or if any patient-depending factors should guide the choice of treatment. The aim of this study is to create a large-scale register of all glaucomatous patients diagnosed, followed-up and treated in a large glaucoma-specialised tertiary centre, to analyse if any specific factor influence the progression of the disease or guide our treatment choice. This should lead to a better understanding of the disease itself and of the factors that should be considered when choosing the best treatment option for each patient, leading to safer, more efficient and more patient-centered care. This registry is thus of great importance for both patients and clinicians in the diagnosis and treatment of glaucoma. The study is an observational analysis of patients' medical data recorded in a large-scale register, both retrospective and prospective.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 5000
Est. completion date January 2030
Est. primary completion date August 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnosis of glaucoma (open-angle, closed-angle, primary or secondary) or ocular hypertension (IOP > 24 mmHg, medicated or not) - Patients who received treatment (medical, laser or surgical) at the Glaucoma Centre, Montchoisi Clinic and Swiss Visio Montchoisi - Age: 18 years old or older - Able and willing to provide informed written or verbal consent Exclusion Criteria: - Patients who are unable to understand the implications of their inclusion in the study or who are unable or unwilling to give informed consent

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Switzerland Swiss Visio Montchoisi Lausanne Vaud

Sponsors (1)

Lead Sponsor Collaborator
Swiss Glaucoma Research Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary IOP changes intraocular pressure (IOP) values compared to baseline 2 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Primary Number of molecules • number of IOP-lowering medications required to maintain the IOP within therapeutic targets compared to baseline 2 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
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