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Clinical Trials/NCT05367193
NCT05367193
Completed
N/A

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

National Taiwan University Hospital1 site in 1 country40 target enrollmentOctober 7, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Patients With Highly Myopic Eyes
Sponsor
National Taiwan University Hospital
Enrollment
40
Locations
1
Primary Endpoint
Number of injections of ICG
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 7, 2022
End Date
March 16, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

  • ICG exposure time(operation day)
  • ILM peeling time(operation day)
  • Total surgical time(Intraoperative)

Study Sites (1)

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