3D Visualization System for Vitreoretinal Diseases in Highly Myopic Eyes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-07

Study Completion Date

2023-03-16

Brief Summary

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

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Detailed Description

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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.

Conditions

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Patients With Highly Myopic Eyes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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

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

Group Type EXPERIMENTAL

pars plana vitrectomy

Intervention Type PROCEDURE

pars plana vitrectomy for vitreoretinal disease in highly myopic eyes

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

Intervention Type DEVICE

Injection of ICG to stain internal limiting membrane

standard binocular microscope pars plana vitrectomy

Group Type ACTIVE_COMPARATOR

pars plana vitrectomy

Intervention Type PROCEDURE

pars plana vitrectomy for vitreoretinal disease in highly myopic eyes

Interventions

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pars plana vitrectomy

pars plana vitrectomy for vitreoretinal disease in highly myopic eyes

Intervention Type PROCEDURE

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

Injection of ICG to stain internal limiting membrane

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No