NCT06274593

Brief Summary

Glaucoma is a chronic disease of the optic nerve, characterized by progressive loss of nerve cells in the retina, leading to progressive loss of peripheral and central vision. There are in fact several types of glaucoma, which is the world's second leading cause of blindness after cataracts, and the leading cause of irreversible blindness. To date, to our knowledge, there is no work analyzing the progression of angiographic OCT in patients with glaucoma. The main aim of this study is to compare the 3-year progression rate of 3 examinations in advanced glaucoma patients: one functional (visual field) and two anatomical (OCTa and OCTrnfl).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
16mo left

Started Apr 2024

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress61%
Apr 2024Sep 2027

First Submitted

Initial submission to the registry

February 14, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 23, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

April 27, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

January 16, 2025

Status Verified

January 1, 2025

Enrollment Period

3 years

First QC Date

February 14, 2024

Last Update Submit

January 14, 2025

Conditions

Glaucoma

Keywords

glaucomaOCTaOCTrnfl

Outcome Measures

Primary Outcomes (3)

  • Compare the progression of vascular density (VD) in advanced glaucoma patients.

    Progression of peripapillary vascular density (VD) (in percent) per sector (8 sectors) with 3-year follow-up.

    3 year

  • Compare the progression of peripapillary retinal nerve fiber (RNFL) thickness) in advanced glaucoma patients.

    Progression of peripapillary nerve fiber thickness (RNFL, in µm) per sector (8 sectors) with 3-year follow-up.

    3 year

  • Compare the progression of visual field in advanced glaucoma patients.

    Progression of visual field deficit (in dB) by sector (8 sectors) with 3-year follow-up

    3 year

Secondary Outcomes (1)

  • CV-OCTrnfl correlation study and CV-OCTa correlation study on measurements made at inclusion and on measurements made during follow-up

    3 years

Interventions

OCTDEVICE

Peripapillary angiography (OCT) at baseline and each year during 3 year

Eligibility Criteria

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

Patients followed at Nantes University Hospital for advanced glaucoma (MD\>10dB in visual field) who had peripapillary angiography OCT, OCTrnfl and visual field at their follow-up consultation.

You may qualify if:

  • Men and women aged 18 and over
  • Patient with glaucoma followed in the ophthalmology department of Nantes University Hospital
  • mean visual field deficit (MD) \>10dB

You may not qualify if:

  • Retinal vascular pathology (moderate to severe non-proliferative diabetic retinopathy, complicated diabetic retinopathy, OVCR/OBVR, OACR/OBAR, NOIAA...) Non-glaucomatous optic neuropathy, neurological pathology leading to visual field deficit (stroke with HLH, quadranopsia, chiasmatic Sd...)
  • PPR (retinal PanPhotocoagulation), retinal cerclage
  • Retinal pathology leading to visual field impairment (e.g. retinitis pigmentosa)
  • AMD and other macular pathologies that can lead to central visual field deficits
  • Significant environmental disorders impairing retinal imaging (e.g. active uveitis, dense cataract)
  • Loss of fixation point preventing visual field formation Pregnant or breast-feeding women
  • Protected adults under guardianship or curatorship
  • with unreliable visual fields (false positives and false negatives \> 33%)
  • with an uninterpretable OCTrnfl or OCTa (artifact, low quality score)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Nantes

Nantes, 44000, France

RECRUITING

Jean-Baptiste Ducloyer

Nantes, 44093, France

NOT YET RECRUITING

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Central Study Contacts

Jean-Baptiste Ducloyer, M.D

CONTACT

02 40 08 34 01jeanbatiste.ducloyer@chu-nantes.fr

Isabelle Orignac, M.D

CONTACT

02 40 08 34 01isabelle.orignac@chu-nantes.fr

Study Design

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

Study Record Dates

First Submitted

February 14, 2024

First Posted

February 23, 2024

Study Start

April 27, 2024

Primary Completion (Estimated)

April 27, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

January 16, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)