3D Visualization System for Vitreoretinal Diseases in Highly Myopic Eyes

Study Overview
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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

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.

Official Title
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Surgical Outcomes and Intraoperative Parameters Evaluation of 3D Visualization System for Vitreoretinal Diseases in Highly Myopic Eyes

Conditions
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Patients With Highly Myopic Eyes

Intervention / Treatment
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* Procedure: pars plana vitrectomy
* Device: NGENUITY® 3D Visualization System (Alcon, TX, USA)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Highly myopic patients (axial length ≥ 26mm, no upper limit) Patient with vitreoretinal pathology that require vitrectomy who had not received previous ICG or BBG-assisted membrane peeling Patient aged ≥ 20 years Exclusion criteria: Patient who had previous ICG or BBG-assisted membrane peeling Patient who received combined vitrectomy and trabeculectomy Patient with endophthalmitis or intraocular foreign body

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pars plana vitrectomy performed using NGENUITY® 3D Visualization System (Alcon, TX, USA)<br>NGENUITY® 3D Visualization System (Alcon, TX, USA) | Procedure: pars plana vitrectomy<br>* pars plana vitrectomy for vitreoretinal disease in highly myopic eyes<br>Device: NGENUITY® 3D Visualization System (Alcon, TX, USA)<br>* Injection of ICG to stain internal limiting membrane<br>|
| Active Comparator: standard binocular microscope pars plana vitrectomy<br>standard binocular microscope pars plana vitrectomy | Procedure: pars plana vitrectomy<br>* pars plana vitrectomy for vitreoretinal disease in highly myopic eyes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | operation day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total surgical time | Total surgical time | Intraoperative | 
| ILM peeling time | ILM peeling time | operation day | 
| ICG exposure time | ICG exposure time | operation day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitreoretinal surgery, high myopia, Pars plana vitrectomy, 3D visualization system