NCT05747144

Multimodal Imaging in Vitreo-retinal Surgery and Macular Dystrophies

Multimodal Imaging in Vitreo-retinal Surgery and Macular Dystrophies: Biomarkers of Morpho-Functional Recovery by Artificial Intelligence

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 18 Months
• Healthy volunteers: Not accepted

Summary

The aim of the study is to identify morphological and functional biomarkers of post-operative recovery after vitreoretinal surgery, using decisional support systems (DSS), based on multimodal big-data analysis by means of machine learning techniques in daily clinical practice

Detailed description

The aim of the study is to identify morphological and functional biomarkers of post-operative recovery after vitreoretinal surgery. Identifying the biomarkers and assessing the predictivity of recovery will make it possible to highlight the categories of patients who can benefit most from surgical treatment, and to target the patient more precisely for personalised medicine and surgery. The introduction of new decisional support systems (DSS), based on multimodal big-data analysis through machine learning techniques in daily clinical practice, is providing new useful information in patient assessment for personalised surgery.

Conditions

• Macular Holes
• Epiretinal Membrane
• Retinal Detachment
• Macular Dystrophies

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Biometry	Biometric measurements performed with IOL Master, if executable Contact or immersion echobiometry if IOL Master cannot be performed
DIAGNOSTIC_TEST	Retinography (Color) + Autofluorescence (AF)	Colour + AF: EIDON, if available (60° not modulable) Colour: COBRA (60° non-modifiable) AF: Spectralis-Heidelberg (choose 55°) Other if available (choose posterior pole examination between 50-60°)
DIAGNOSTIC_TEST	OCT B-scan and OCT angiography (OCTA)	OCT B-scan: 2 scans (6 mm) 1 cross line OCTA: 3x3 mm + 6x6 mm centred on the fovea 4.5 mm centred on the optic nerve
DIAGNOSTIC_TEST	Microperimetry	1\) fixation pattern 2) retinal sensitivity map
DIAGNOSTIC_TEST	Electrophysiological exams	Layer-by-layer assessment of the retina using focal ERG and pattern ERG according to standardised and published methods , For patients with visus \< 3/10 and unstable fixation a protocol based on component analysis of the photopic ERG from diffuse flash will be used.

Timeline

• Start date: 2021-01-15
• Primary completion: 2025-01-15
• Completion: 2025-01-16
• First posted: 2023-02-28
• Last updated: 2024-02-13

Locations

1 site across 1 country: Italy