GLAUcoma Diagnostic and Imaging Analysis (GLAUDIA) Study

NCT07210216 | Not Yet Recruiting

• 1 other identifier: 6441
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Glaucoma Open-Angle Primary; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• Correlation between OCT structural parameters and visual field indices

  Baseline to 24 months

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Study Design

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

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: October 7, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: October 7, 2025

Record last verified: 2025-09