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

Comparison of 3D Visualization and Microscope for VR Surgery Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05113212
• Other study ID #: 2997CESC
• Status: Completed
• Phase: N/A
• Start date: November 19, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: December 2022
• Source: Santa Maria della Misericordia Rovigo Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Comparison of 3D Visualization and Microscope for VR Surgery

Intervention

Device:
• Macular surgery with NGENUITY surgical display system
Patient undergoes VR surgery with visualization using heads up display 3D monitor viewed by the operating surgeon
• Macular surgery with standard operating microscope
Patient undergoes VR surgery with visualization using standard operating microscope

Locations

Country	Name	City	State
Italy	Santa Maria della Misericordia Hospital	Rovigo

Sponsors (2)

Lead Sponsor	Collaborator
Anna Rita Daniele, MD	Alcon Research

Country where clinical trial is conducted

Italy, 

Outcome

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