3D Visualization System for Vitreoretinal Diseases in Highly Myopic Eyes

National Taiwan University

Status: Completed

Conditions: Patients With Highly Myopic Eyes

Treatments: Procedure: pars plana vitrectomy; Device: NGENUITY® 3D Visualization System (Alcon, TX, USA)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05367193

202110065DINC

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 20+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

pars plana vitrectomy performed using NGENUITY® 3D Visualization System (Alcon, TX, USA)

Experimental group

Description:

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

Treatment:

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

Procedure: pars plana vitrectomy

standard binocular microscope pars plana vitrectomy

Active Comparator group

Description:

standard binocular microscope pars plana vitrectomy

Treatment:

Procedure: pars plana vitrectomy