NCT06829810

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,528

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2025

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

February 11, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 17, 2025

Completed
Last Updated

March 19, 2025

Status Verified

March 1, 2025

Enrollment Period

Same day

First QC Date

February 11, 2025

Last Update Submit

March 18, 2025

Conditions

Keywords

Intraocular pressureglaucomaocular hypertensionglaucoma surgerynon penetrating deep sclerectomytrabeculectomyglaucoma drainage device

Outcome Measures

Primary Outcomes (1)

  • Modelisation of IOP profile

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

    Baseline

Secondary Outcomes (7)

  • Modelisation of IOP profile of Non-perforating deep sclerectomy

    Baseline

  • Modelisation of IOP profile of Trabeculectomy

    Baseline

  • Modelisation of IOP profile of Glaucoma drainage device

    Baseline

  • Modelisation of IOP profile of MIGS Istent

    Baseline

  • Modelisation of IOP profile of MIGS XEN

    Baseline

  • +2 more secondary outcomes

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with glaucoma or ocular hypertonia

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Bordeaux

Bordeaux, France

Location

MeSH Terms

Conditions

GlaucomaOcular Hypertension

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2025

First Posted

February 17, 2025

Study Start

January 15, 2025

Primary Completion

January 15, 2025

Study Completion

January 15, 2025

Last Updated

March 19, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations