Skip to main content
OpenTrials
Completed

NCT Number: NCT05113212

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Comparison of 3D Visualization and Microscope for VR Surgery Eye Diseases Retinal Diseases Retinal Perforations

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Santa Maria della Misericordia Hospital

Rovigo, 45100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Macular surgery with standard operating microscope

Device

Patient undergoes VR surgery with visualization using standard operating microscope

Primary outcomes

  1. SANFL detection

    Time frame: 2 weeks after surgery

    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

Secondary outcomes

  1. Intraoperative time

    Time frame: during surgery

    Mean duration of the surgical procedure

  2. ILM staining

    Time frame: during surgery

    Number of internal limiting membrane staining procedures necessary

  3. ILM grasping

    Time frame: during surgery

    Number of ILM grasping attempts.

  4. Light

    Time frame: during surgery

    Lumen of light used

  5. Surgeon ergonomics

    Time frame: during surgery

    Number of episodes of both back and neck pain

  6. BCVA

    Time frame: baseline, 1 month and 3 months after surgery

    Best Corrected Visual Acuity

Sponsors and collaborators

Lead sponsor

Anna Rita Daniele, MD

Other

Collaborators

  • Alcon Research

Registry information

Official study title

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.

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 9, 2021
Registry last updated
Dec 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.