Skip to main content
OpenTrials
Completed

NCT Number: NCT05367193

3D Visualization System for Vitreoretinal Diseases in Highly Myopic Eyes

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, 100, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pars plana vitrectomy

Procedure

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

Primary outcomes

  1. Number of injections of ICG

    Time frame: operation day

    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

Secondary outcomes

  1. Total surgical time

    Time frame: Intraoperative

    Total surgical time

  2. ILM peeling time

    Time frame: operation day

    ILM peeling time

  3. ICG exposure time

    Time frame: operation day

    ICG exposure time

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Collaborators

  • Alcon Research

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 10, 2022
Registry last updated
Jun 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.