GLAUcoma Diagnostic and Imaging Analysis (GLAUDIA) Study | NCT07210216

Studies
GLAUcoma Diagnostic and Imaging Analysis (GLAUDIA) Study

NCT07210216

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Status

Not yet recruiting

Last Update Posted

Oct 7, 2025Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Glaucoma Open-Angle Primary
Ocular Hypertension

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2025Estimated

Primary Completion Date

Dec 2027Estimated

Completion Date

Jun 2028Estimated

First Submitted Date

Sep 29, 2025

First Submission Date that Met QC Criteria

Sep 29, 2025

First Posted Date

Oct 7, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 29, 2025

Last Update Posted Date

Oct 7, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This observational study aims to identify early diagnostic markers of glaucomatous damage by combining functional and structural assessments. Patients with primary open-angle glaucoma and ocular hypertension will undergo comprehensive ophthalmological evaluation, including visual field testing and multimodal imaging of the optic nerve and retina. Both retrospective and prospective data will be collected. The main objective is to define new diagnostic paradigms for detecting early glaucomatous changes and to improve the accuracy of current clinical practice in glaucoma management.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence of early glaucomatous damage detected by multimodal imaging	Evaluation of structural parameters from OCT and OCTA and functional indices from visual field testing to detect early glaucomatous damage in ocular hypertensive and glaucoma patients.	Baseline to 24 months

Secondary Outcomes

Measure	Description	Time Frame
Correlation between OCT structural parameters and visual field indices	Analysis of the association between RNFL/GCC thickness and visual field MD, PSD, and other indices.	Baseline to 24 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age between 40 and 90 years.
Best-corrected visual acuity ≥ 0.1 LogMAR (≥ 8/10).
For primary open-angle glaucoma (POAG):
IOP ≥ 21 mmHg with normal visual field and/or normal optic nerve head/RNFL, or
Suspicious optic nerve head (excavation), or
Reproducible glaucomatous visual field defect.
POAG patients stratified by visual field mean deviation (MD): -3 to -10 dB (S1-S2 Brusini classification).

Exclusion Criteria:

Best-corrected visual acuity worse than 0.1 LogMAR (< 8/10).
Ocular surgery in the last 6 months (except uncomplicated cataract extraction).
Previous vitreoretinal surgery for macular pathologies (e.g., macular pucker, macular hole) or retinal detachment.
High myopia (> -3 diopters).
Optic disc anomalies not attributable to glaucoma (tilted disc, papillary drusen, other morphological/functional anomalies).
Severe motor disability preventing proper positioning for tests.
Cognitive impairment reducing test reliability.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Adult patients (40-90 years) with primary open-angle glaucoma, ocular hypertension, or healthy controls, recruited at the Glaucoma Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS.

Sampling Method

Non-Probability Sample

ID	Term
D005902	Glaucoma, Open-Angle
D009798	Ocular Hypertension

ID	Term
D005901	Glaucoma
D005128	Eye Diseases