Long-shaft Vitrectomy Probe in Highly Myopic Eyes

June 14, 2023 updated by: National Taiwan University Hospital

The Surgical Outcomes of Long-shaft Vitrectomy Probe for Vitreoretinal Diseases in Highly Myopic Eyes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: study group
Highly myopic patients with vitreoretinal disease requiring pars plana vitrectomy. The 30mm (shaft length) vitrectomy probe (25 gauge) would be used in the surgery.
Procedure: 25 gauge pars plana vitrectomy
25 gauge pars plana vitrectomy
Active Comparator: control group
Highly myopic patients with vitreoretinal disease requiring pars plana vitrectomy. The 27mm (shaft length) vitrectomy probe (25 gauge) would be used in the surgery.
Procedure: 25 gauge pars plana vitrectomy
25 gauge pars plana vitrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
trocar removal rate
Time Frame: intra-operative
trocar removal would be performed if the length of vitrectomy probe was not adequate
intra-operative
operation time
Time Frame: intra-operative
record the operation time and time of core vitrectomy
intra-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
instrument bending
Time Frame: intraoperative
record the occurrence of instrument bending
intraoperative

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: Until post-op 6 month
the presence of vitreous hemorrhage, retinal hemorrhage, retinal detachment, choroidal hemorrhage, endophthalmitis
Until post-op 6 month
wound status evaluation by slit lamp biomicroscopy
Time Frame: until post-op 1 month
the presence of subconjunctival hemorrhage, chemosis, subconjunctival air, wound suture
until post-op 1 month
anatomical success evaluation by optical coherence tomography and indirect ophthalmolscopy
Time Frame: post-op 3 month
whether the disease was successfully treated
post-op 3 month
anatomical success evaluation by optical coherence tomography and indirect ophthalmolscopy
Time Frame: post-op 6 month
whether the disease was successfully treated
post-op 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2021

Primary Completion (Actual)

June 17, 2022

Study Completion (Actual)

February 7, 2023

Study Registration Dates

First Submitted

February 21, 2021

First Submitted That Met QC Criteria

May 20, 2021

First Posted (Actual)

May 26, 2021

Study Record Updates

Last Update Posted (Estimated)

June 16, 2023

Last Update Submitted That Met QC Criteria

June 14, 2023

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202008057DIFD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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