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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05113212

Enrollment

Registered

2021-11-09

Start date

2021-11-19

Completion date

2022-09-30

Last updated

2022-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Comparison of 3D Visualization and Microscope for VR Surgery

Keywords

Ngenuity, VR Surgery, Pucker, Macular Hole

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.

Interventions

DEVICEMacular surgery with NGENUITY surgical display system

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

DEVICEMacular surgery with standard operating microscope

Patient undergoes VR surgery with visualization using standard operating microscope

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
SANFL detection	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

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026