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.
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.
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.
- Conditions
- Glaucoma, Ocular Hypertension
- 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.
Modelisation of IOP profile
Modelisation of IOP profile of all surgical techniques and additional procedures during the follow-up
Measured: Baseline
Secondary outcomes (7)
Modelisation of IOP profile of Non-perforating deep sclerectomy
Modelisation of IOP profile of Non-perforating deep sclerectomy
Measured: Baseline
Modelisation of IOP profile of Trabeculectomy
Modelisation of IOP profile of Trabeculectomy
Measured: Baseline
Modelisation of IOP profile of Glaucoma drainage device
Modelisation of IOP profile of Glaucoma drainage device
Measured: Baseline
Modelisation of IOP profile of MIGS Istent
Modelisation of IOP profile of MIGS Istent
Measured: Baseline
Modelisation of IOP profile of MIGS XEN
Modelisation of IOP profile of MIGS XEN
Measured: Baseline
Modelisation of IOP profile of High Intensity Focused ultrasound
Modelisation of IOP profile of High Intensity Focused ultrasound
Measured: Baseline
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.
- First posted17 Feb 2025
- Study start15 Jan 2025
- Primary completion15 Jan 2025
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcomes of Glaucoma Surgery in a Real-life Setting: the Agora Registry Study
- ClinicalTrials.gov ID
- NCT06829810
- Acronym / sponsor ID
- GLAUCOSURG / CHUBX 2023/89
- Conditions
- Glaucoma, Ocular Hypertension
- Keywords
- Intraocular pressure, glaucoma, ocular hypertension, glaucoma surgery, non penetrating deep sclerectomy, trabeculectomy, glaucoma drainage device
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,528 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with glaucoma or ocular hypertonia
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- Refusal to participate
- Patients physically or psychologically unable to understand the study and the research protocol
- Patients under legal protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modelisation of intraocular pressure profileModelisation of IOP profile of all surgical techniques and additional procedures during the follow-up | Other | – |
Primary outcome
Modelisation of IOP profile
Time frame: Baseline
Modelisation of IOP profile of all surgical techniques and additional procedures during the follow-up
7 secondary outcomes
Modelisation of IOP profile of Non-perforating deep sclerectomy
Time frame: Baseline
Modelisation of IOP profile of Trabeculectomy
Time frame: Baseline
Modelisation of IOP profile of Glaucoma drainage device
Time frame: Baseline
Modelisation of IOP profile of MIGS Istent
Time frame: Baseline
Modelisation of IOP profile of MIGS XEN
Time frame: Baseline
Modelisation of IOP profile of High Intensity Focused ultrasound
Time frame: Baseline
Modelisation of IOP profile of CycloDiode
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.