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

Anna Rita Daniele, MD

Status: Completed

Conditions: Comparison of 3D Visualization and Microscope for VR Surgery

Treatments: Device: Macular surgery with standard operating microscope; Device: Macular surgery with NGENUITY surgical display system

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05113212

2997CESC

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 21+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 2 patient groups

Control arm

Active Comparator group

Description:

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

Treatment:

Device: Macular surgery with standard operating microscope

Experimental arm

Experimental group

Description:

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

Treatment:

Device: Macular surgery with NGENUITY surgical display system