Multimodal Imaging in Vitreo-retinal Surgery and Macular Dystrophies (MICAI)

February 10, 2024 updated by: RIZZO STANISLAO, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Rome, Italy, 00168
        • Recruiting
        • Prof. Stanislao Rizzo
        • Contact:
          • Stanislao Rizzo, MD,PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

All patients to undergo vitreo-retinal surgery for macular disease (i.e.Macular hole, epiretinal membranes, Retinal detachment, Macular dystrophies (retinal pre-prosthesis).

Description

Inclusion Criteria:

  • All patients to undergo vitreo-retinal surgery for:

    1. Macular hole
    2. Epiretinal membranes
    3. Retinal detachment
    4. 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2021

Primary Completion (Estimated)

January 15, 2025

Study Completion (Estimated)

January 16, 2025

Study Registration Dates

First Submitted

February 17, 2023

First Submitted That Met QC Criteria

February 17, 2023

First Posted (Actual)

February 28, 2023

Study Record Updates

Last Update Posted (Actual)

February 13, 2024

Last Update Submitted That Met QC Criteria

February 10, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3680

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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