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

Surgery Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04381611
• Other study ID #: INTEGRAL
• Status: Enrolling by invitation
• Start date: January 15, 2019
• Est. completion date: January 15, 2030

Study information

• Verified date: May 2022
• Source: Swiss Vision Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30000
• Est. completion date: January 15, 2030
• Est. primary completion date: January 15, 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 100 Years

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Switzerland	SwissVisio Montchoisi	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Kaweh Mansouri

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with IOP reduction mmHg	Final Intra Ocular Pressure <20% compared to baseline	12 month
Primary	Patients with quantitative OCT variations ( RNFL, µm)	Variation of RNFL before and after treatment ( laser, surgery, drug..)	12 month
Primary	Number of patients with quantitative VF variation ( MD, dB)	Visual Field MD variation before and after treatment ( laser, surgery, drug..)	12 month
Primary	Number of patients with quantitative VF variation (LV, dB)	Visual Field MD variation before and after treatment ( laser, surgery, drug..)	12 months
Secondary	Number of operations received by a patients	Number of operations undertaken by each patient	12 month
Secondary	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
Secondary	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
Secondary	Anterior segment OCT variations: ACA (°), SSA (°)	variations of these measurements before and after procedure ( surgery or laser)	12 month
Secondary	Anterior segment OCT variations: AOD (mm)	variations of these measurements before and after procedure ( surgery or laser)	12 month
Secondary	Anterior segment OCT variations: TISA (mm2)	variations of these measurements before and after procedure ( surgery or laser)	12 month