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

Randomized, Prospective, Descriptive and Comparative Clinical Study of Macular Grasping Damage in Patients Undergoing Pars Plana Vitrectomy and Peeling of the Internal Limiting Membrane, Operated by Traditional Microscope or NGENUITY® 3D Visualization System With Heads-up Display System. A Pilot Study.

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.

Study Overview

• Status: Completed
• Conditions: Comparison of 3D Visualization and Microscope for VR Surgery
• Intervention / Treatment: Device: Macular surgery with standard operating microscope; Device: Macular surgery with NGENUITY surgical display system

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rovigo, Italy, 45100
    • Santa Maria della Misericordia Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control arm; patients affected by macular pucker or macular hole, whose internal limiting membrane peeling is performed using a traditional optical microscope (Leica F40)	Device: Macular surgery with standard operating microscope; Patient undergoes VR surgery with visualization using standard operating microscope
Experimental: 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)	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SANFL detection	Post-surgical analysis of SANFL (Swelling of the Arcuate Nerve Fiber Layer) measured on infrared, blue auto-fluorescence images and OCT images of peripapillary region	2 weeks after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative time	Mean duration of the surgical procedure	during surgery
ILM staining	Number of internal limiting membrane staining procedures necessary	during surgery
ILM grasping	Number of ILM grasping attempts.	during surgery
Light	Lumen of light used	during surgery
Surgeon ergonomics	Number of episodes of both back and neck pain	during surgery
BCVA	Best Corrected Visual Acuity	baseline, 1 month and 3 months after surgery

Collaborators and Investigators

• Sponsor: Anna Rita Daniele, MD
• Collaborators: Alcon Research

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2021
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: October 11, 2021
• First Submitted That Met QC Criteria: November 6, 2021
• First Posted (Actual): November 9, 2021

Study Record Updates

• Last Update Posted (Estimate): December 22, 2022
• Last Update Submitted That Met QC Criteria: December 21, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Ngenuity; VR Surgery; Pucker; Macular Hole
• Other Study ID Numbers: 2997CESC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes