3D Visualization System for Vitreoretinal Diseases in Highly Myopic Eyes

Surgical Outcomes and Intraoperative Parameters Evaluation of 3D Visualization System for Vitreoretinal Diseases in Highly Myopic Eyes

To investigate the surgical outcomes and intraoperative parameters evaluation of 3D visualization system for vitreoretinal diseases in highly myopic eyes

Study Overview

• Status: Completed
• Conditions: Patients With Highly Myopic Eyes
• Intervention / Treatment: Procedure: pars plana vitrectomy; Device: NGENUITY® 3D Visualization System (Alcon, TX, USA)

Detailed Description

The investigators aimed to compare the safety and efficacy of NGENUITY® 3D Visualization System (Alcon, TX, USA) in vitreoretinal surgery of highly myopic patients with standard binocular microscope pars plana vitrectomy of highly myopic patients. This is a randomized controlled study and will enroll highly myopic patients who had axial length more than 26 mm and needed vitreoretinal surgery. The enrolled patients will be randomized into "NGENUITY® 3D Visualization System (Alcon, TX, USA) group"(trial group) and "standard binocular microscope pars plana vitrectomy group"(controlled group). The investigators will compare the number of injections of dye (indocyanine green (ICG) or brilliant blue G (BBG)), total surgical time, total peeling time, exposure time of dye, power of endoilluminator, the rate of probe bending, surgical time, postoperative intraocular pressure (IOP), the rate of wound leakage, hypotony, subconjunctival hemorrhage, vitreous hemorrhage, retinal hemorrhage, and endophthalmitis, best-corrected visual acuity (BCVA), structural changes shown on OCT and so on between the two groups.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

1. Highly myopic patients (axial length ≥ 26mm, no upper limit)
2. Patient with vitreoretinal pathology that require vitrectomy who had not received previous ICG or BBG-assisted membrane peeling
3. Patient aged ≥ 20 years

Exclusion criteria:

1. Patient who had previous ICG or BBG-assisted membrane peeling
2. Patient who received combined vitrectomy and trabeculectomy
3. Patient with endophthalmitis or intraocular foreign body

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: pars plana vitrectomy performed using NGENUITY® 3D Visualization System (Alcon, TX, USA); NGENUITY® 3D Visualization System (Alcon, TX, USA)	Procedure: pars plana vitrectomy; pars plana vitrectomy for vitreoretinal disease in highly myopic eyes; Device: NGENUITY® 3D Visualization System (Alcon, TX, USA); Injection of ICG to stain internal limiting membrane
Active Comparator: standard binocular microscope pars plana vitrectomy	Procedure: pars plana vitrectomy; pars plana vitrectomy for vitreoretinal disease in highly myopic eyes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of injections of ICG	Fixed and minimal concentration: ICG (25mg/vial) is diluted to 0.05% Fixed time: Each injection is 15 sec Interval time for washout: consistent as 10 sec	operation day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total surgical time	Total surgical time	Intraoperative
ILM peeling time	ILM peeling time	operation day
ICG exposure time	ICG exposure time	operation day

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: Alcon Research
• Investigators: Principal Investigator: Ho Tzyy-Chang, MD, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2022
• Primary Completion (Actual): March 16, 2023
• Study Completion (Actual): March 16, 2023

Study Registration Dates

• First Submitted: April 26, 2022
• First Submitted That Met QC Criteria: May 4, 2022
• First Posted (Actual): May 10, 2022

Study Record Updates

• Last Update Posted (Actual): June 17, 2024
• Last Update Submitted That Met QC Criteria: June 13, 2024
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: vitreoretinal surgery; Pars plana vitrectomy; high myopia; 3D visualization system
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: 202110065DINC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data may be provided under reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No