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Multimodal Imaging in Vitreo-retinal Surgery and Macular Dystrophies

NCT05747144 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2024-02-13

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Eligibility

Min Age
18 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-15
Primary Completion
2025-01-15
Completion
2025-01-16

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05747144 on ClinicalTrials.gov