3D Visualization System for Vitreoretinal Diseases in Highly Myopic Eyes

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05367193

Collaborator

Alcon Services AG, Taiwan Branch (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Patients With Highly Myopic Eyes	Procedure: pars plana vitrectomy Device: NGENUITY® 3D Visualization System (Alcon, TX, USA)	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

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

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

Procedure: pars plana vitrectomy

pars plana vitrectomy for vitreoretinal disease in highly myopic eyes

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

Injection of ICG to stain internal limiting membrane

Active Comparator: standard binocular microscope pars plana vitrectomy

standard binocular microscope pars plana vitrectomy

Procedure: pars plana vitrectomy

pars plana vitrectomy for vitreoretinal disease in highly myopic eyes

Outcome Measures

Primary Outcome Measures

Number of injections of ICG [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 Outcome Measures

Total surgical time [Intraoperative]
Total surgical time
ILM peeling time [operation day]
ILM peeling time
ICG exposure time [operation day]
ICG exposure time

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Taiwan University Hospital	Taipei		Taiwan	100

Sponsors and Collaborators

National Taiwan University Hospital
Alcon Services AG, Taiwan Branch

Investigators

Principal Investigator: Ho Tzyy-Chang, MD, National Taiwan University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

National Taiwan University Hospital

ClinicalTrials.gov Identifier:

NCT05367193

Other Study ID Numbers:

202110065DINC

First Posted:

May 10, 2022

Last Update Posted:

Aug 11, 2022

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by National Taiwan University Hospital

vitreoretinal surgery

high myopia

Pars plana vitrectomy

3D visualization system

Additional relevant MeSH terms:

Myopia

Study Results

No Results Posted as of Aug 11, 2022