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

NCT05113212 | Completed FDA Device

• 1 other identifier: 2997CESC
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Ngenuity; VR Surgery; Pucker; Macular Hole

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Intraoperative time

  during surgery

• ILM staining

  during surgery

• ILM grasping

  during surgery

• Light

  during surgery

• Surgeon ergonomics

  during surgery

Study Arms (2)

Control arm

ACTIVE COMPARATOR

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

Experimental arm

EXPERIMENTAL

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

Interventions

Macular surgery with NGENUITY surgical display system DEVICE

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

Experimental arm

Macular surgery with standard operating microscope DEVICE

Patient undergoes VR surgery with visualization using standard operating microscope

Control arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anna Rita Daniele, MD: lead
• Alcon Research: collaborator

Study Sites (1)

Santa Maria della Misericordia Hospital

Rovigo, 45100, Italy

Location

MeSH Terms

Conditions

Retinal Perforations

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor

Model Details: Dual-arm, pilot, randomized, prospective, descriptive and comparative clinical study

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: November 9, 2021
• Study Start: November 19, 2021
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: December 22, 2022

Record last verified: 2022-12

Locations

IT (1)