Clinical trial NCT06829810: Long-term Outcomes of Glaucoma Surgery in a Real-life Setting: the Agora Registry Study
Official title: Long-term Outcomes of Glaucoma Surgery in a Real-life Setting: the Agora Registry Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Ocular Hypertension
Keywords: Intraocular pressure
glaucoma
ocular hypertension
glaucoma surgery
non penetrating deep sclerectomy
trabeculectomy
glaucoma drainage device
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2025-02-17
Enrollment: 1528
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with glaucoma or ocular hypertonia

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.

Eligibility criteria: 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

Primary outcomes:
measure: Modelisation of IOP profile
timeFrame: Baseline
Secondary outcomes:
measure: Modelisation of IOP profile of Non-perforating deep sclerectomy
timeFrame: Baseline
measure: Modelisation of IOP profile of Trabeculectomy
timeFrame: Baseline
measure: Modelisation of IOP profile of Glaucoma drainage device
timeFrame: Baseline
measure: Modelisation of IOP profile of MIGS Istent
timeFrame: Baseline
measure: Modelisation of IOP profile of MIGS XEN
timeFrame: Baseline
measure: Modelisation of IOP profile of High Intensity Focused ultrasound
timeFrame: Baseline
measure: Modelisation of IOP profile of CycloDiode
timeFrame: Baseline
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux
Study officials:
References: