Multimodal Imaging in Vitreo-retinal Surgery and Macular Dystrophies

NCT05747144 | Recruiting DMC

• 1 other identifier: 3680
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Macular Holes; Epiretinal Membrane; Retinal Detachment; Macular Dystrophies

Keywords

vitreoretinal surgery; machine learning; decisional support systems

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Identify predictive differences according to diagnosis

  3 years

• Correlating with the age of patients

  3 years

• Correlate with age of onset of disease

  3 years

Study Arms (4)

Macular hole

Patients affected by macular hole.

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

Epiretinal membranes

Patients affected by epiretinal membrane.

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

Retinal detachment

Patients affected by retinal detachment.

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

Macular dystrophies

Patients affected by 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

Interventions

Biometry DIAGNOSTIC_TEST

Biometric measurements performed with IOL Master, if executable Contact or immersion echobiometry if IOL Master cannot be performed

Epiretinal membranes; Macular dystrophies; Macular hole; Retinal detachment

Retinography (Color) + Autofluorescence (AF) DIAGNOSTIC_TEST

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°)

Epiretinal membranes; Macular dystrophies; Macular hole; Retinal detachment

OCT B-scan and OCT angiography (OCTA) DIAGNOSTIC_TEST

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

Epiretinal membranes; Macular dystrophies; Macular hole; Retinal detachment

Microperimetry DIAGNOSTIC_TEST

1\) fixation pattern 2) retinal sensitivity map

Epiretinal membranes; Macular dystrophies; Macular hole; Retinal detachment

Electrophysiological exams DIAGNOSTIC_TEST

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; Macular dystrophies; Macular hole; Retinal detachment

Eligibility Criteria

• Age: 18 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• All patients to undergo vitreo-retinal surgery for:
• Macular hole
• Epiretinal membranes
• Retinal detachment
• Macular dystrophies (retinal pre-prosthesis)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Prof. Stanislao Rizzo

Rome, 00168, Italy

RECRUITING

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MeSH Terms

Conditions

Retinal Perforations; Epiretinal Membrane; Retinal Detachment; Macular Degeneration

Interventions

Color

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Retinal Degeneration

Intervention Hierarchy (Ancestors)

Light; Optical Phenomena; Physical Phenomena

Central Study Contacts

Maria Cristina Savastano, MD,PhD

CONTACT

+39 3384443002; mariacristina.savastano@unicatt.it

Alfonso Savastano, MD,PhD

CONTACT

alfonso.savastano@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: February 28, 2023
• Study Start: January 15, 2021
• Primary Completion: January 15, 2025
• Study Completion: January 16, 2025
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)