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Long-term Outcomes of Glaucoma Surgery in a Real-life Setting: the Agora Registry Study

Long-term Outcomes of Glaucoma Surgery in a Real-life Setting: the Agora Registry Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06829810
Acronym
GLAUCOSURG
Enrollment
1528
Registered
2025-02-17
Start date
2025-01-15
Completion date
2025-01-15
Last updated
2025-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma, Ocular Hypertension

Keywords

Intraocular pressure, glaucoma, ocular hypertension, glaucoma surgery, non penetrating deep sclerectomy, trabeculectomy, glaucoma drainage device

Brief summary

Retrospective cohort study performed at Bordeaux University Hospital, which aims to analyze long-term safety and efficacy of different techniques of glaucoma surgery including filtering glaucoma surgeries, glaucoma drainage devices or minimally invasive glaucoma surgeries. All patients operated on in the department in the standard of care were proposed to be included in the AGORA registry study. The main outcome will be to define a modelisation of IOP profile based on the surgical technique. Secondary outcomes will be to analyze factors influencing IOP evolution as well as long-term safety and efficacy outcomes of the included surgical techniques.

Detailed description

Glaucoma is a progressive degenerative optic neuropathy characterized by excavation of the optic nerve and the appearance, deepening and widening of visual field deficits (scotomas). It is the leading cause of irreversible blindness in France and worldwide. Although glaucoma is a progressive degenerative optic neuropathy with a multifactorial mechanism, all therapeutic studies have shown that lowering intraocular pressure (IOP) remains the only modulable causal factor that can stabilize or slow disease progression. It is also estimated that the glaucoma population requiring a surgery is approximately 5-10%. There is a wide range of surgical techniques for lowering IOP including filtering surgeries (trabeculectomy, non penetrating deep sclerectomy), glaucoma drainage devices and minimally invasive glaucoma surgeries. All these surgeries are acknowledged to reduce intraocular pressure but are also associated with risk of severe perioperative complications depending on glaucoma severity or ophthalmological characteristics. In addition some of them require additional procedures to maintain treatment success. These additional procedures are the consequence of IOP fluctuations over time following glaucoma surgeries. Although IOP is the main factors to control glaucoma over time, these real-life IOP fluctuations limit the use and the interpretability of survival analysis for long-term outcomes of each surgical procedure. The aim of this study is to define a modelisation of IOP profile based on the surgical techniques and to analyze factors influencing IOP evolution as well as long-term safety and efficacy outcomes of the included surgical techniques. Demographical, ophthalmological, surgical parameters and all follow-up visits data will be collected in the standard of care of all patients who accepted to be included in the AGORA registry study. From November 2010 to April 2023, 2420 surgical procedures were recorded in the registry including 1584 Non penetrating deep sclerectomy, 212 trabeculectomy, 354 Istent or 95 high Intensity Focused Ultrasound. IOP evolution over time will be described for each surgical technique and a statistical model will be defined. The modelisation of IOP with time and the description of risk factors of success or failure over the long-term of each surgical technique should help clinicians to make a more personalized surgical decision in order to maintain visual performances of glaucoma patients with time.

Interventions

OTHERModelisation of intraocular pressure profile

Modelisation of IOP profile of all surgical techniques and additional procedures during the follow-up

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All patients over the age of 18 with glaucoma or ocular hypertonia treated in the ophthalmology department of Bordeaux University Hospital between 2011 and 2022.

Exclusion criteria

* Refusal to participate * Patients physically or psychologically unable to understand the study and the research protocol * Patients under legal protection

Design outcomes

Primary

MeasureTime frameDescription
Modelisation of IOP profileBaselineModelisation of IOP profile of all surgical techniques and additional procedures during the follow-up

Secondary

MeasureTime frameDescription
Modelisation of IOP profile of TrabeculectomyBaselineModelisation of IOP profile of Trabeculectomy
Modelisation of IOP profile of Glaucoma drainage deviceBaselineModelisation of IOP profile of Glaucoma drainage device
Modelisation of IOP profile of MIGS IstentBaselineModelisation of IOP profile of MIGS Istent
Modelisation of IOP profile of Non-perforating deep sclerectomyBaselineModelisation of IOP profile of Non-perforating deep sclerectomy
Modelisation of IOP profile of High Intensity Focused ultrasoundBaselineModelisation of IOP profile of High Intensity Focused ultrasound
Modelisation of IOP profile of CycloDiodeBaselineModelisation of IOP profile of CycloDiode
Modelisation of IOP profile of MIGS XENBaselineModelisation of IOP profile of MIGS XEN

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026