Clinical trial NCT06227299: INTEGRAL Study: A Longitudinal Study of Surgeries and Lasers in Glaucoma
Official title: INTEGRAL Study: A Longitudinal Study of Surgeries and Lasers in Glaucoma: Long-term Results and Success Predictors Analysed From a Large-scale Retrospective and Prospective Glaucoma Register
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Glaucoma
Lead sponsor: Swiss Glaucoma Research Foundation
Sponsor class: OTHER
First posted: 2024-01-26
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The register includes all patients diagnosed with glaucoma (primary, secondary, open and closed-angle) who received treatment at the Glaucoma Centre, at Montchoisi Clinic and Swiss Visio Montchoisi, Lausanne since 2014. There is no limit to the number of patients included in the register.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: IOP changes
timeFrame: 2 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
measure: Number of molecules
timeFrame: 2 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Swiss Visio Montchoisi
state: Vaud
Study officials:
affiliation: Swiss Glaucoma Research Foundation
name: Kaweh Mansouri, MD
role: PRINCIPAL_INVESTIGATOR
References: