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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05367193

Enrollment

Registered

2022-05-10

Start date

2022-10-07

Completion date

2023-03-16

Last updated

2024-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients With Highly Myopic Eyes

Keywords

vitreoretinal surgery, high myopia, Pars plana vitrectomy, 3D visualization system

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.

Interventions

PROCEDUREpars plana vitrectomy

pars plana vitrectomy for vitreoretinal disease in highly myopic eyes

DEVICENGENUITY® 3D Visualization System (Alcon, TX, USA)

Injection of ICG to stain internal limiting membrane

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026