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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
64
Patient undergoes VR surgery with visualization using heads up display 3D monitor viewed by the operating surgeon
Patient undergoes VR surgery with visualization using standard operating microscope
Santa Maria della Misericordia Hospital
Rovigo, Italy
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
Time frame: 2 weeks after surgery
Intraoperative time
Mean duration of the surgical procedure
Time frame: during surgery
ILM staining
Number of internal limiting membrane staining procedures necessary
Time frame: during surgery
ILM grasping
Number of ILM grasping attempts.
Time frame: during surgery
Light
Lumen of light used
Time frame: during surgery
Surgeon ergonomics
Number of episodes of both back and neck pain
Time frame: during surgery
BCVA
Best Corrected Visual Acuity
Time frame: baseline, 1 month and 3 months after surgery
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