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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Glaucoma Open-Angle, Glaucoma Eye, Glaucoma; Drugs, Glaucoma, Angle-Closure. Basic parameters: 1 year — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Number of patients with IOP reduction mmHg [Time frame: 12 month]
- Patients with quantitative OCT variations ( RNFL, μm) [Time frame: 12 month]
- Number of patients with quantitative VF variation ( MD, dB) [Time frame: 12 month]
- Number of patients with quantitative VF variation (LV, dB) [Time frame: 12 months]
Secondary outcome measures (6)
- Number of operations received by a patients [Time frame: 12 month]
- Number of patients undergoing a specific ocular surgical or laser procedure [Time frame: 12 month]
- Number of lowering IOP drugs ( molecules) taken by each patient [Time frame: 12 month]
- Anterior segment OCT variations: ACA (°), SSA (°) [Time frame: 12 month]
- Anterior segment OCT variations: AOD (mm) [Time frame: 12 month]
- Anterior segment OCT variations: TISA (mm2) [Time frame: 12 month]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Switzerland · 1 center
- SwissVisio Montchoisi — Lausanne
Publications
- 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. PMID 32890108
Identifiers
NCT: NCT04381611 · INTEGRAL