Multimodal Imaging in Vitreo-retinal Surgery and Macular Dystrophies

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Macular Holes, Epiretinal Membrane, Retinal Detachment, Macular Dystrophies

Intervention / Treatment
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* Diagnostic Test: Biometry
* Diagnostic Test: Retinography (Color) + Autofluorescence (AF)
* Diagnostic Test: OCT B-scan and OCT angiography (OCTA)
* Diagnostic Test: Microperimetry
* Diagnostic Test: Electrophysiological exams


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients to undergo vitreo-retinal surgery for: Macular hole Epiretinal membranes Retinal detachment Macular dystrophies (retinal pre-prosthesis) Exclusion Criteria: Patients under 18 years of age will be excluded; patients in whom morphological examinations cannot be performed due to poor cooperation or opacity of the dioptric media (e.g. corneal pathology). Quality of morphological images inadequate for post acquisition processing (<6/10).

Ages Eligible for Study
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Minimum Age: 18 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Macular hole<br>Patients affected by macular hole. | Diagnostic Test: Biometry<br>* Biometric measurements performed with IOL Master, if executable Contact or immersion echobiometry if IOL Master cannot be performed<br>Diagnostic Test: Retinography (Color) + Autofluorescence (AF)<br>* 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°)<br>Diagnostic Test: OCT B-scan and OCT angiography (OCTA)<br>* 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<br>Diagnostic Test: Microperimetry<br>* 1) fixation pattern 2) retinal sensitivity map<br>Diagnostic Test: Electrophysiological exams<br>* 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.<br>|
| Epiretinal membranes<br>Patients affected by epiretinal membrane. | Diagnostic Test: Biometry<br>* Biometric measurements performed with IOL Master, if executable Contact or immersion echobiometry if IOL Master cannot be performed<br>Diagnostic Test: Retinography (Color) + Autofluorescence (AF)<br>* 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°)<br>Diagnostic Test: OCT B-scan and OCT angiography (OCTA)<br>* 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<br>Diagnostic Test: Microperimetry<br>* 1) fixation pattern 2) retinal sensitivity map<br>Diagnostic Test: Electrophysiological exams<br>* 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.<br>|
| Retinal detachment<br>Patients affected by retinal detachment. | Diagnostic Test: Biometry<br>* Biometric measurements performed with IOL Master, if executable Contact or immersion echobiometry if IOL Master cannot be performed<br>Diagnostic Test: Retinography (Color) + Autofluorescence (AF)<br>* 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°)<br>Diagnostic Test: OCT B-scan and OCT angiography (OCTA)<br>* 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<br>Diagnostic Test: Microperimetry<br>* 1) fixation pattern 2) retinal sensitivity map<br>Diagnostic Test: Electrophysiological exams<br>* 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.<br>|
| Macular dystrophies<br>Patients affected by macular dystrophies. | Diagnostic Test: Biometry<br>* Biometric measurements performed with IOL Master, if executable Contact or immersion echobiometry if IOL Master cannot be performed<br>Diagnostic Test: Retinography (Color) + Autofluorescence (AF)<br>* 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°)<br>Diagnostic Test: OCT B-scan and OCT angiography (OCTA)<br>* 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<br>Diagnostic Test: Microperimetry<br>* 1) fixation pattern 2) retinal sensitivity map<br>Diagnostic Test: Electrophysiological exams<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictivity of morphological-functional radiomic data | Rate of predictivity of morphological-functional radiomic data to establish the grade of recovery in the post-operative period by means of an artificial intelligence (AI) machine learning model. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify predictive differences according to diagnosis | Subdivision into subgroups in order to identify predictive differences according to diagnosis | 3 years | 
| Correlating with the age of patients | Identify predictive differences according to diagnosis and correlate them with the age of patients | 3 years | 
| Correlate with age of onset of disease | Identify predictive differences according to diagnosis and correlate them with the age of onset of disease | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitreoretinal surgery, machine learning, decisional support systems