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

Dr. Kaweh Mansouri

Status

Invitation-only

Conditions

Glaucoma, Pigmentary

Glaucoma Capsulare

Surgery

Glaucoma Open-Angle

Glaucoma Congenital

Glaucoma, Neovascular

Glaucoma Secondary

Glaucoma Eye

Glaucoma, Angle-Closure

Glaucoma; Drugs

Study type

Observational

Funder types

Other

Identifiers

NCT04381611

INTEGRAL

Details and patient eligibility

About

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.

Full 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.

Enrollment

30,000 estimated patients

Sex

All

Ages

1 to 100 years old

Volunteers

Accepts Healthy Volunteers

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