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

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: Retinal Detachment; Macular Dystrophies; Macular Holes; Epiretinal Membrane

Treatments: Diagnostic Test: Microperimetry; Diagnostic Test: Electrophysiological exams; Diagnostic Test: Retinography (Color) + Autofluorescence (AF); Diagnostic Test: OCT B-scan and OCT angiography (OCTA); Diagnostic Test: Biometry

Study type: Observational

Funder types: Other

Identifiers

NCT05747144

3680

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ months old

Volunteers: No Healthy Volunteers

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).

Trial design

100 participants in 4 patient groups

Macular hole

Description:

Patients affected by macular hole.

Treatment:

Diagnostic Test: Retinography (Color) + Autofluorescence (AF)

Diagnostic Test: Biometry

Diagnostic Test: Electrophysiological exams

Diagnostic Test: Microperimetry

Diagnostic Test: OCT B-scan and OCT angiography (OCTA)

Epiretinal membranes

Description:

Patients affected by epiretinal membrane.

Treatment:

Diagnostic Test: Retinography (Color) + Autofluorescence (AF)

Diagnostic Test: Biometry

Diagnostic Test: Electrophysiological exams

Diagnostic Test: Microperimetry

Diagnostic Test: OCT B-scan and OCT angiography (OCTA)

Retinal detachment

Description:

Patients affected by retinal detachment.

Treatment:

Diagnostic Test: Retinography (Color) + Autofluorescence (AF)

Diagnostic Test: Biometry

Diagnostic Test: Electrophysiological exams

Diagnostic Test: Microperimetry

Diagnostic Test: OCT B-scan and OCT angiography (OCTA)

Macular dystrophies

Description:

Patients affected by macular dystrophies.

Treatment:

Diagnostic Test: Retinography (Color) + Autofluorescence (AF)

Diagnostic Test: Biometry

Diagnostic Test: Electrophysiological exams

Diagnostic Test: Microperimetry

Diagnostic Test: OCT B-scan and OCT angiography (OCTA)