3D Visualization System for Vitreoretinal Diseases in Highly Myopic Eyes

National Taiwan University Hospital40 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Patients With Highly Myopic Eyes

Interventions

pars plana vitrectomyPROCEDURE

pars plana vitrectomy for vitreoretinal disease in highly myopic eyes

NGENUITY® 3D Visualization System (Alcon, TX, USA)DEVICE

Injection of ICG to stain internal limiting membrane

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

National Taiwan University Hospital

Taipei, Taiwan

Outcomes

Primary Outcomes

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

Time frame: operation day

Secondary Outcomes

Total surgical time

Time frame: Intraoperative

ILM peeling time

Time frame: operation day

ICG exposure time

Time frame: operation day

Data from ClinicalTrials.gov

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