An interventional study of pars plana vitrectomy and NGENUITY® 3D Visualization System (Alcon, TX, USA) in Patients With Highly Myopic Eyes, sponsored by National Taiwan University Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2024-06-17.
Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment
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.
984 studies on the registry are indexed under Myopia; 210 are open to participants now.
This study's enrollment of 40 is below the median of 80 across 783 interventional studies indexed under Myopia.
Browse Myopia studies →National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
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Exclusion criteria:
NGENUITY® 3D Visualization System (Alcon, TX, USA)
Procedure: pars plana vitrectomy · Device: NGENUITY® 3D Visualization System (Alcon, TX, USA)
standard binocular microscope pars plana vitrectomy
Procedure: pars plana vitrectomy
pars plana vitrectomy for vitreoretinal disease in highly myopic eyes
Injection of ICG to stain internal limiting membrane
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
Total surgical time
Total surgical time
Time frame: Intraoperative
ILM peeling time
ILM peeling time
Time frame: operation day
ICG exposure time
ICG exposure time
Time frame: operation day
Plan to share: No — Data may be provided under reasonable request.
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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National Taiwan University Hospital