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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 30,000 (estimated)
• Sponsor: Dr. Kaweh Mansouri · Academic / Other
• Sex: All
• Age: 1 Year – 100 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Timeline

• Start date: 2019-01-15
• Primary completion: 2030-01-15
• Completion: 2030-01-15
• First posted: 2020-05-11
• Last updated: 2022-05-05

Locations

1 site across 1 country: Switzerland