Clinical trial NCT04381611: 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
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 Open-Angle
Glaucoma Eye
Glaucoma; Drugs
Glaucoma, Angle-Closure
Glaucoma Secondary
Glaucoma, Neovascular
Glaucoma Congenital
Surgery
Glaucoma, Pigmentary
Glaucoma Capsulare
Lead sponsor: Swiss Vision Network
Sponsor class: OTHER
First posted: 2020-05-11
Enrollment: 30000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient suffering or suspected of glaucoma and treated at Montchoisi Clinic

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.

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

Primary outcomes:
measure: Number of patients with IOP reduction mmHg
timeFrame: 12 month
measure: Patients with quantitative OCT variations ( RNFL, μm)
timeFrame: 12 month
measure: Number of patients with quantitative VF variation ( MD, dB)
timeFrame: 12 month
measure: Number of patients with quantitative VF variation (LV, dB)
timeFrame: 12 months
Secondary outcomes:
measure: Number of operations received by a patients
timeFrame: 12 month
measure: Number of patients undergoing a specific ocular surgical or laser procedure
timeFrame: 12 month
measure: Number of lowering IOP drugs ( molecules) taken by each patient
timeFrame: 12 month
measure: Anterior segment OCT variations: ACA (°), SSA (°)
timeFrame: 12 month
measure: Anterior segment OCT variations: AOD (mm)
timeFrame: 12 month
measure: Anterior segment OCT variations: TISA (mm2)
timeFrame: 12 month
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: SwissVisio Montchoisi
state: Vaud
Study officials:
References:
citation: Meduri E, Gillmann K, Bravetti GE, Niegowski LJ, Mermoud A, Weinreb RN, Mansouri K. Iridocorneal Angle Assessment After Laser Iridotomy With Swept-source Optical Coherence Tomography. J Glaucoma. 2020 Nov;29(11):1030-1035. doi: 10.1097/IJG.0000000000001654.