Clinical trial NCT05747144: Multimodal Imaging in Vitreo-retinal Surgery and Macular Dystrophies
Official title: Multimodal Imaging in Vitreo-retinal Surgery and Macular Dystrophies: Biomarkers of Morpho-Functional Recovery by Artificial Intelligence
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Macular Holes
Epiretinal Membrane
Retinal Detachment
Macular Dystrophies
Keywords: vitreoretinal surgery
machine learning
decisional support systems
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-02-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Predictivity of morphological-functional radiomic data
timeFrame: 3 years
Secondary outcomes:
measure: Identify predictive differences according to diagnosis
timeFrame: 3 years
measure: Correlating with the age of patients
timeFrame: 3 years
measure: Correlate with age of onset of disease
timeFrame: 3 years
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Prof. Stanislao Rizzo
Study officials:
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