NCT05367193

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 10, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

October 7, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2023

Completed
Last Updated

June 17, 2024

Status Verified

November 1, 2021

Enrollment Period

5 months

First QC Date

April 26, 2022

Last Update Submit

June 13, 2024

Conditions

Patients With Highly Myopic Eyes

Keywords

vitreoretinal surgeryhigh myopiaPars plana vitrectomy3D visualization system

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Total surgical time

    Intraoperative

  • ILM peeling time

    operation day

  • ICG exposure time

    operation day

Study Arms (2)

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

EXPERIMENTAL

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

Procedure: pars plana vitrectomyDevice: NGENUITY® 3D Visualization System (Alcon, TX, USA)

standard binocular microscope pars plana vitrectomy

ACTIVE COMPARATOR

standard binocular microscope pars plana vitrectomy

Procedure: pars plana vitrectomy

Interventions

pars plana vitrectomyPROCEDURE

pars plana vitrectomy for vitreoretinal disease in highly myopic eyes

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

Injection of ICG to stain internal limiting membrane

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

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patient who had previous ICG or BBG-assisted membrane peeling
  • Patient who received combined vitrectomy and trabeculectomy
  • Patient with endophthalmitis or intraocular foreign body

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Study Officials

  • Ho Tzyy-Chang, MD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2022

First Posted

May 10, 2022

Study Start

October 7, 2022

Primary Completion

March 16, 2023

Study Completion

March 16, 2023

Last Updated

June 17, 2024

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Data may be provided under reasonable request.

Locations

TW(1)