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GlaucomaGLAUCOSURGNCT06829810

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

An observational study of Glaucoma and Ocular Hypertension, run by University Hospital, Bordeaux at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glaucoma, Ocular Hypertension
What is being tested?
Modelisation of intraocular pressure profile
How many people
1,528 participants
Where
1 siteFrance
Study dates
15 Jan 2025to 15 Jan 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with glaucoma or ocular hypertonia

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site
  • CHU Bordeaux

    Bordeaux

Other trials in France

About this study

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.

Read the 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.

Being tested
Modelisation of intraocular pressure profile
Keywords
Intraocular pressure, glaucoma, ocular hypertension, glaucoma surgery, non penetrating deep sclerectomy, trabeculectomy, glaucoma drainage device
Medical subject headings
Glaucoma, Ocular Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Modelisation of intraocular pressure profileOther

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Modelisation of IOP profile

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

    Measured: Baseline

Secondary outcomes (7)
  1. Modelisation of IOP profile of Non-perforating deep sclerectomy

    Modelisation of IOP profile of Non-perforating deep sclerectomy

    Measured: Baseline

  2. Modelisation of IOP profile of Trabeculectomy

    Modelisation of IOP profile of Trabeculectomy

    Measured: Baseline

  3. Modelisation of IOP profile of Glaucoma drainage device

    Modelisation of IOP profile of Glaucoma drainage device

    Measured: Baseline

  4. Modelisation of IOP profile of MIGS Istent

    Modelisation of IOP profile of MIGS Istent

    Measured: Baseline

  5. Modelisation of IOP profile of MIGS XEN

    Modelisation of IOP profile of MIGS XEN

    Measured: Baseline

  6. Modelisation of IOP profile of High Intensity Focused ultrasound

    Modelisation of IOP profile of High Intensity Focused ultrasound

    Measured: Baseline

  7. Modelisation of IOP profile of CycloDiode

    Modelisation of IOP profile of CycloDiode

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2025
  2. Study start15 Jan 2025
  3. Primary completion15 Jan 2025
  4. Study completion15 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
1,528 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06829810
Sponsor's protocol ID
CHUBX 2023/89
Acronym
GLAUCOSURG
Status last verified
Mar 2025
First submitted
11 Feb 2025
Last updated
19 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Glaucoma and Ocular Hypertension, run by University Hospital, Bordeaux at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Modelisation of IOP profile (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.

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