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

Not Applicable

Completed

• Conditions: Comparison of 3D Visualization and Microscope for VR Surgery
• Interventions: Device: Macular surgery with standard operating microscope; Device: Macular surgery with NGENUITY surgical display system

• Registration Number: NCT05113212
• Lead Sponsor: Anna Rita Daniele, MD

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-11
• Study First Submitted QC: 2021-11-06
• Study First Posted: 2021-11-09
• Study Start: 2021-11-19
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-21
• Last Update Posted: 2022-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control arm	Macular surgery with standard operating microscope	patients affected by macular pucker or macular hole, whose internal limiting membrane peeling is performed using a traditional optical microscope (Leica F40)
Experimental arm	Macular surgery with NGENUITY surgical display system	patients affected by macular pucker or macular hole whose internal limiting membrane peeling is performed by 3D heads-up microscopy system (NGenuity 3D)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Santa Maria della Misericordia Hospital; 🇮🇹 Rovigo, Italy