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Long-shaft Vitrectomy Probe in Highly Myopic Eyes

Primary Purpose

Retinal Diseases, High Myopia

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
25 gauge pars plana vitrectomy
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinal Diseases focused on measuring High myopia, Pars plana vitrectomy, Vitreoretinal disease

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Highly myopic patients (axial length > 26mm) with vitreoretinal diseases or maculopathy requiring pars plana vitrectomy

Exclusion Criteria:

  • Previous history of pars plana vitrectomy
  • Surgical plan combining encircling buckle
  • Silicone oil or perfluorocarbon liquid use intraoperatively
  • Previous history of pterygium surgery, trabeculectomy, glaucoma surgery
  • Previous history of corneal, conjunctival, or scleral laceration
  • History of connective tissue disease

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

study group

control group

Arm Description

Highly myopic patients with vitreoretinal disease requiring pars plana vitrectomy. The 30mm (shaft length) vitrectomy probe (25 gauge) would be used in the surgery.

Highly myopic patients with vitreoretinal disease requiring pars plana vitrectomy. The 27mm (shaft length) vitrectomy probe (25 gauge) would be used in the surgery.

Outcomes

Primary Outcome Measures

trocar removal rate
trocar removal would be performed if the length of vitrectomy probe was not adequate
operation time
record the operation time and time of core vitrectomy

Secondary Outcome Measures

instrument bending
record the occurrence of instrument bending

Full Information

First Posted
February 21, 2021
Last Updated
June 14, 2023
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04902170
Brief Title
Long-shaft Vitrectomy Probe in Highly Myopic Eyes
Official Title
The Surgical Outcomes of Long-shaft Vitrectomy Probe for Vitreoretinal Diseases in Highly Myopic Eyes
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
July 22, 2021 (Actual)
Primary Completion Date
June 17, 2022 (Actual)
Study Completion Date
February 7, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

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
This study aimed to compare the safety and efficacy of vitrectomy probe with different shaft lengths in vitreoretinal surgery of highly myopic patients. In this randomized controlled study, highly myopic patients who had axial length more than 26 mm and needed vitreoretinal surgery will be enrolled. The enrolled patients will be randomized into "30 mm shaft length group"(trial group) and "27mm shaft length group"(controlled group). We will compare the rate of wound leakage, hypotony, subconjunctival hemorrhage, probe bending, trocar removal, and endophthalmitis between the two groups. We would like to evaluate the efficacy and safety of the 30 mm shaft length vitrectomy probe.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Diseases, High Myopia
Keywords
High myopia, Pars plana vitrectomy, Vitreoretinal disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Experimental
Arm Description
Highly myopic patients with vitreoretinal disease requiring pars plana vitrectomy. The 30mm (shaft length) vitrectomy probe (25 gauge) would be used in the surgery.
Arm Title
control group
Arm Type
Active Comparator
Arm Description
Highly myopic patients with vitreoretinal disease requiring pars plana vitrectomy. The 27mm (shaft length) vitrectomy probe (25 gauge) would be used in the surgery.
Intervention Type
Procedure
Intervention Name(s)
25 gauge pars plana vitrectomy
Intervention Description
25 gauge pars plana vitrectomy
Primary Outcome Measure Information:
Title
trocar removal rate
Description
trocar removal would be performed if the length of vitrectomy probe was not adequate
Time Frame
intra-operative
Title
operation time
Description
record the operation time and time of core vitrectomy
Time Frame
intra-operative
Secondary Outcome Measure Information:
Title
instrument bending
Description
record the occurrence of instrument bending
Time Frame
intraoperative
Other Pre-specified Outcome Measures:
Title
Complications
Description
the presence of vitreous hemorrhage, retinal hemorrhage, retinal detachment, choroidal hemorrhage, endophthalmitis
Time Frame
Until post-op 6 month
Title
wound status evaluation by slit lamp biomicroscopy
Description
the presence of subconjunctival hemorrhage, chemosis, subconjunctival air, wound suture
Time Frame
until post-op 1 month
Title
anatomical success evaluation by optical coherence tomography and indirect ophthalmolscopy
Description
whether the disease was successfully treated
Time Frame
post-op 3 month
Title
anatomical success evaluation by optical coherence tomography and indirect ophthalmolscopy
Description
whether the disease was successfully treated
Time Frame
post-op 6 month

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) with vitreoretinal diseases or maculopathy requiring pars plana vitrectomy Exclusion Criteria: Previous history of pars plana vitrectomy Surgical plan combining encircling buckle Silicone oil or perfluorocarbon liquid use intraoperatively Previous history of pterygium surgery, trabeculectomy, glaucoma surgery Previous history of corneal, conjunctival, or scleral laceration History of connective tissue disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tzyy-Chang Ho
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

12. IPD Sharing Statement

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Long-shaft Vitrectomy Probe in Highly Myopic Eyes

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