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 Overview
=================
Brief Summary
-----------------
The study is an observational analysis of patients' medical data recorded in a large-scale register, both retrospective (for patients operated and data recorded before 2018) and prospective (for data collected after 2018) in nature.Patients' medical data contained in the register will be analysed to determine the efficacy of the treatments they received during their follow-up at the investigation centre.

Detailed Description
-----------------
This study involves the creation and analysis of a large-scale register including all patients suffering from glaucoma, currently and previously followed-up and treated at a single tertiary centre in Lausanne, Switzerland. The design of the study is longitudinal, observational and comparative. Patients are recruited retrospectively if they attended the research centre before September 2018, and prospectively if they attend the centre from this month onwards. Their inclusion does not affect their care, treatment choice or follow-up. All data of recruited patients is be kept in their medical notes until a specific analysis is launched. Data is then exported from their medical notes into a coded database for analysis. At the end of each analysis session (defined as the publication of the related article), all exported data is fully anonymised. Data analysis will aim to assess the long-term efficacy, safety profile, and factors predictive of success/failure of treatments performed. To ensure the quality of all included data, health-related information will be extracted directly from the medical notes and coded into the register by a Clinical Research Associate. Conformity of the process and recorded data will be confirmed by regular internal auditing. For quality assurance the Ethics Committee may visit the research sites. Direct access to the source data and all project related files and documents must be granted on such occasions.

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

Conditions
-----------------
Glaucoma, Neovascular, Glaucoma Open-Angle, Glaucoma Eye, Glaucoma; Drugs, Glaucoma, Angle-Closure, Glaucoma Secondary, Glaucoma Congenital, Surgery, Glaucoma, Pigmentary, Glaucoma Capsulare

Participation Criteria
=================
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 Able and willing to provide informed written or verbal consent Exclusion Criteria: Patient who are unable to understand the implications of their inclusion in the study or who are unable or unwilling to give informed consent

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary Glaucoma<br> | |
| Glaucoma Surgery<br> | |
| Glaucoma Laser<br> | |
| Glaucoma Surgery Combined<br> | |
| Glaucoma treatment<br> | |
| Glaucoma imaging<br> | |
| Glaucoma co-morbidity<br> | |
| Glaucoma untreated<br> | |
| Glaucoma Suspect<br> | |
| Secondary Glaucoma<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with IOP reduction mmHg | Final Intra Ocular Pressure <20% compared to baseline | 12 month | 
| Patients with quantitative OCT variations ( RNFL, μm) | Variation of RNFL before and after treatment ( laser, surgery, drug..) | 12 month | 
| Number of patients with quantitative VF variation ( MD, dB) | Visual Field MD variation before and after treatment ( laser, surgery, drug..) | 12 month | 
| Number of patients with quantitative VF variation (LV, dB) | Visual Field MD variation before and after treatment ( laser, surgery, drug..) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of operations received by a patients | Number of operations undertaken by each patient | 12 month | 
| Number of patients undergoing a specific ocular surgical or laser procedure | Number of patients undertaking different types of ocular procedures ( deep sclerectomy, cataract, LPI, SLT,...) | 12 month | 
| Number of lowering IOP drugs ( molecules) taken by each patient | Number of molecules used by each patient (e.g Cosopt: 2 molecules, Xalatan: 1...) | 12 month | 
| Anterior segment OCT variations: ACA (°), SSA (°) | variations of these measurements before and after procedure ( surgery or laser) | 12 month | 
| Anterior segment OCT variations: AOD (mm) | variations of these measurements before and after procedure ( surgery or laser) | 12 month | 
| Anterior segment OCT variations: TISA (mm2) | variations of these measurements before and after procedure ( surgery or laser) | 12 month |