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

NCT ID: NCT05113212

Last Updated: 2022-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-19

Study Completion Date

2022-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Comparison of 3D Visualization and Microscope for VR Surgery

Keywords

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Ngenuity VR Surgery Pucker Macular Hole

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Dual-arm, pilot, randomized, prospective, descriptive and comparative clinical study
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Control arm

patients affected by macular pucker or macular hole, whose internal limiting membrane peeling is performed using a traditional optical microscope (Leica F40)

Group Type ACTIVE_COMPARATOR

Macular surgery with standard operating microscope

Intervention Type DEVICE

Patient undergoes VR surgery with visualization using standard operating microscope

Experimental arm

patients affected by macular pucker or macular hole whose internal limiting membrane peeling is performed by 3D heads-up microscopy system (NGenuity 3D)

Group Type EXPERIMENTAL

Macular surgery with NGENUITY surgical display system

Intervention Type DEVICE

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

Interventions

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Macular surgery with NGENUITY surgical display system

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

Intervention Type DEVICE

Macular surgery with standard operating microscope

Patient undergoes VR surgery with visualization using standard operating microscope

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients affected by macular pucker or macular hole, whose internal limiting membrane peeling need to be performed
* Willing and able to understand and sign an informed consent
* Willing and able to undergo postoperative examinations of the protocol program:
* ≥ 21 years of age, of both sexes and any race

Exclusion Criteria

* History of ocular trauma or amblyopia.
* Other ocular pathologies (glaucoma, uveitis, diabetic retinopathy, diabetic macular edema, macular degeneration, Irvine Gass Syndrome, degenerative myopia, malformation of the optic disc, i.e.: tilted disc, optic disc pit, posterior staphyloma)
* Multiple procedures programmed during the surgery
* Pregnancy, lactation or programmed pregnancy during the course of the study.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role collaborator

Anna Rita Daniele, MD

OTHER

Sponsor Role lead

Responsible Party

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Anna Rita Daniele, MD

Medical Doctor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Santa Maria della Misericordia Hospital

Rovigo, , Italy

Site Status

Countries

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Italy

Other Identifiers

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2997CESC

Identifier Type: -

Identifier Source: org_study_id