An observational study in Macular Holes, Epiretinal Membrane and Retinal Detachment, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Recruiting at 1 site in Italy. Open to participants aged 18 Months and older. Per ClinicalTrials.gov, last updated 2024-02-13.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational
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
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.
139 studies on the registry are indexed under Retinal Perforations; 22 are open to participants now.
This study's planned enrollment of 100 is above the median of 50 across 43 observational studies indexed under Retinal Perforations.
Browse Retinal Perforations studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients to undergo vitreo-retinal surgery for macular disease (i.e.Macular hole, epiretinal membranes, Retinal detachment, Macular dystrophies (retinal pre-prosthesis).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
All patients to undergo vitreo-retinal surgery for:
Exclusion Criteria:
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
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
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
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
Biometric measurements performed with IOL Master, if executable Contact or immersion echobiometry if IOL Master cannot be performed
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°)
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
1) fixation pattern 2) retinal sensitivity map
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.
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.
Time frame: 3 years
Identify predictive differences according to diagnosis
Subdivision into subgroups in order to identify predictive differences according to diagnosis
Time frame: 3 years
Correlating with the age of patients
Identify predictive differences according to diagnosis and correlate them with the age of patients
Time frame: 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
Time frame: 3 years
Plan to share: No
Started Jan 2021 (actual). Primary completion is estimated for Jan 2025, 48 months after the start.
Of 16 observational studies under Retinal Perforations, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 144. This study's planned 48 months is above that.
How these figures are worked out, and which studies are left out of them.
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