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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Comparison of 3D Visualization and Microscope for VR Surgery

Intervention / Treatment
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* Device: Macular surgery with NGENUITY surgical display system
* Device: Macular surgery with standard operating microscope


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Dual-arm, pilot, randomized, prospective, descriptive and comparative clinical study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control arm<br>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<br>* Patient undergoes VR surgery with visualization using standard operating microscope<br>|
| Experimental: Experimental arm<br>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<br>* Patient undergoes VR surgery with visualization using heads up display 3D monitor viewed by the operating surgeon<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ngenuity, VR Surgery, Pucker, Macular Hole