3D Visualization System for Vitreoretinal Diseases in Highly Myopic Eyes
Primary Purpose
Patients With Highly Myopic Eyes
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
pars plana vitrectomy
NGENUITY® 3D Visualization System (Alcon, TX, USA)
Sponsored by
About this trial
This is an interventional treatment trial for Patients With Highly Myopic Eyes focused on measuring vitreoretinal surgery, high myopia, Pars plana vitrectomy, 3D visualization system
Eligibility Criteria
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
Sites / Locations
- National Taiwan University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
pars plana vitrectomy performed using NGENUITY® 3D Visualization System (Alcon, TX, USA)
standard binocular microscope pars plana vitrectomy
Arm Description
NGENUITY® 3D Visualization System (Alcon, TX, USA)
standard binocular microscope pars plana vitrectomy
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Total surgical time
Total surgical time
ILM peeling time
ILM peeling time
ICG exposure time
ICG exposure time
Full Information
NCT ID
NCT05367193
First Posted
April 26, 2022
Last Updated
October 30, 2022
Sponsor
National Taiwan University Hospital
Collaborators
Alcon Research
1. Study Identification
Unique Protocol Identification Number
NCT05367193
Brief Title
3D Visualization System for Vitreoretinal Diseases in Highly Myopic Eyes
Official Title
Surgical Outcomes and Intraoperative Parameters Evaluation of 3D Visualization System for Vitreoretinal Diseases in Highly Myopic Eyes
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 7, 2022 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
Collaborators
Alcon Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To investigate the surgical outcomes and intraoperative parameters evaluation of 3D visualization system for vitreoretinal diseases in highly myopic eyes
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Highly Myopic Eyes
Keywords
vitreoretinal surgery, high myopia, Pars plana vitrectomy, 3D visualization system
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
pars plana vitrectomy performed using NGENUITY® 3D Visualization System (Alcon, TX, USA)
Arm Type
Experimental
Arm Description
NGENUITY® 3D Visualization System (Alcon, TX, USA)
Arm Title
standard binocular microscope pars plana vitrectomy
Arm Type
Active Comparator
Arm Description
standard binocular microscope pars plana vitrectomy
Intervention Type
Procedure
Intervention Name(s)
pars plana vitrectomy
Intervention Description
pars plana vitrectomy for vitreoretinal disease in highly myopic eyes
Intervention Type
Device
Intervention Name(s)
NGENUITY® 3D Visualization System (Alcon, TX, USA)
Intervention Description
Injection of ICG to stain internal limiting membrane
Primary Outcome Measure Information:
Title
Number of injections of ICG
Description
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
Secondary Outcome Measure Information:
Title
Total surgical time
Description
Total surgical time
Time Frame
Intraoperative
Title
ILM peeling time
Description
ILM peeling time
Time Frame
operation day
Title
ICG exposure time
Description
ICG exposure time
Time Frame
operation day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
TSUI MEI-CHI
Phone
0972653056
Email
meichitsui@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ho Tzyy-Chang, MD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ho Tzyy-Chang, MD
Phone
0972651538
Email
hotc@ntuh.gov.tw
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data may be provided under reasonable request.
Learn more about this trial
3D Visualization System for Vitreoretinal Diseases in Highly Myopic Eyes
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