MICAI: Multimodal Imaging in Vitreo-retinal Surgery and Macular Dystrophies

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05747144

Collaborator

(none)

100

Enrollment

Location

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Macular Holes Epiretinal Membrane Retinal Detachment Macular Dystrophies	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

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.

Study Design

Study Type:

Observational

Actual Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 15, 2021

Anticipated Primary Completion Date :

Jan 15, 2024

Anticipated Study Completion Date :

Jan 16, 2024

Arms and Interventions

Arm	Intervention/Treatment
Macular hole Patients affected by macular hole.	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.
Epiretinal membranes Patients affected by epiretinal membrane.	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.
Retinal detachment Patients affected by retinal detachment.	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.
Macular dystrophies Patients affected by macular dystrophies.	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.

Outcome Measures

Primary Outcome Measures

Predictivity of morphological-functional radiomic data [3 years]
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.

Secondary Outcome Measures

Identify predictive differences according to diagnosis [3 years]
Subdivision into subgroups in order to identify predictive differences according to diagnosis
Correlating with the age of patients [3 years]
Identify predictive differences according to diagnosis and correlate them with the age of patients
Correlate with age of onset of disease [3 years]
Identify predictive differences according to diagnosis and correlate them with the age of onset of disease

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Months and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).