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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Glaucoma, Angle-Closure; Surgery; Glaucoma, Neovascular; Glaucoma Eye; Glaucoma; Drugs; Glaucoma, Pigmentary; Glaucoma Secondary; Glaucoma Open-Angle; Glaucoma Congenital; Glaucoma Capsulare

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.

• Study Type: Observational
• Enrollment (Anticipated): 30000

Contacts and Locations

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1006
      • SwissVisio Montchoisi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Any patient suffering or suspected of glaucoma and treated at Montchoisi Clinic

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

10

Cohorts and Interventions

Group / Cohort
Primary Glaucoma
Glaucoma Surgery
Glaucoma Laser
Glaucoma Surgery Combined
Glaucoma treatment
Glaucoma imaging
Glaucoma co-morbidity
Glaucoma untreated
Glaucoma Suspect
Secondary Glaucoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with IOP reduction mmHg	Final Intra Ocular Pressure <20% compared to baseline	12 month
Patients with quantitative OCT variations ( RNFL, μm)	Variation of RNFL before and after treatment ( laser, surgery, drug..)	12 month
Number of patients with quantitative VF variation ( MD, dB)	Visual Field MD variation before and after treatment ( laser, surgery, drug..)	12 month
Number of patients with quantitative VF variation (LV, dB)	Visual Field MD variation before and after treatment ( laser, surgery, drug..)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of operations received by a patients	Number of operations undertaken by each patient	12 month
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
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
Anterior segment OCT variations: ACA (°), SSA (°)	variations of these measurements before and after procedure ( surgery or laser)	12 month
Anterior segment OCT variations: AOD (mm)	variations of these measurements before and after procedure ( surgery or laser)	12 month
Anterior segment OCT variations: TISA (mm2)	variations of these measurements before and after procedure ( surgery or laser)	12 month

Collaborators and Investigators

• Sponsor: Dr. Kaweh Mansouri

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2019
• Primary Completion (Anticipated): January 15, 2030
• Study Completion (Anticipated): January 15, 2030

Study Registration Dates

• First Submitted: April 30, 2020
• First Submitted That Met QC Criteria: May 5, 2020
• First Posted (Actual): May 11, 2020

Study Record Updates

• Last Update Posted (Actual): May 5, 2022
• Last Update Submitted That Met QC Criteria: May 4, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Congenital Abnormalities; Ocular Hypertension; Eye Abnormalities; Infant, Newborn, Diseases; Uveal Diseases; Iris Diseases; Glaucoma; Glaucoma, Open-Angle; Hydrophthalmos; Glaucoma, Neovascular; Glaucoma, Angle-Closure; Exfoliation Syndrome
• Other Study ID Numbers: INTEGRAL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No