3D Visualization System for Vitreoretinal Diseases in Highly Myopic Eyes

Not Applicable

Completed

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

• Registration Number: NCT05367193
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2021-11
• Study First Submitted: 2022-04-26
• Study First Submitted QC: 2022-05-04
• Study First Posted: 2022-05-10
• Study Start: 2022-10-07
• Primary Completion: 2023-03-16
• Study Completion: 2023-03-16
• Last Update Submitted: 2024-06-13
• Last Update Posted: 2024-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pars plana vitrectomy performed using NGENUITY® 3D Visualization System (Alcon, TX, USA)	pars plana vitrectomy	NGENUITY® 3D Visualization System (Alcon, TX, USA)
standard binocular microscope pars plana vitrectomy	pars plana vitrectomy	standard binocular microscope pars plana vitrectomy
pars plana vitrectomy performed using NGENUITY® 3D Visualization System (Alcon, TX, USA)	NGENUITY® 3D Visualization System (Alcon, TX, USA)	NGENUITY® 3D Visualization System (Alcon, TX, USA)

Primary Outcome Measures

Name	Time	Method
Number of injections of ICG	operation day	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

Secondary Outcome Measures

Name	Time	Method
ILM peeling time	operation day	ILM peeling time
Total surgical time	Intraoperative	Total surgical time
ICG exposure time	operation day	ICG exposure time

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan