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Damages From Macular Grasping During Vitrectomy Comparing Traditional and 3D Microscope

NCT05113212 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2022-12-22

No results posted yet for this study

Summary

Randomized, prospective, descriptive and comparative clinical study. The comparison is between a group of patients affected by macular pucker or macular hole, whose macular peeling is performed using a traditional optical microscope (Leica F40) - control arm, and a group of patients affected by macular pucker or macular hole whose macular peeling is performed by 3D heads-up microscopy system (NGenuity 3D, Alcon) - experimental arm.

It is a blind study for both the operator that collects data and for the statistician.

Conditions

  • Comparison of 3D Visualization and Microscope for VR Surgery

Interventions

DEVICE

Macular surgery with NGENUITY surgical display system

Patient undergoes VR surgery with visualization using heads up display 3D monitor viewed by the operating surgeon

DEVICE

Macular surgery with standard operating microscope

Patient undergoes VR surgery with visualization using standard operating microscope

Sponsors & Collaborators

  • Alcon Research

    collaborator INDUSTRY

  • Anna Rita Daniele, MD

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-19
Primary Completion
2022-09-30
Completion
2022-09-30
FDA Device
Yes

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 NCT05113212 on ClinicalTrials.gov