Long-shaft Vitrectomy Probe in Highly Myopic Eyes

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04902170
Collaborator
(none)
84
1
2
10.3
8.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: 25 gauge pars plana vitrectomy
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
84 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
The Surgical Outcomes of Long-shaft Vitrectomy Probe for Vitreoretinal Diseases in Highly Myopic Eyes
Actual Study Start Date :
Jul 22, 2021
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. trocar removal rate [intra-operative]

    trocar removal would be performed if the length of vitrectomy probe was not adequate

  2. operation time [intra-operative]

    record the operation time and time of core vitrectomy

Secondary Outcome Measures

  1. instrument bending [intraoperative]

    record the occurrence of instrument bending

Other Outcome Measures

  1. Complications [Until post-op 6 month]

    the presence of vitreous hemorrhage, retinal hemorrhage, retinal detachment, choroidal hemorrhage, endophthalmitis

  2. wound status evaluation by slit lamp biomicroscopy [until post-op 1 month]

    the presence of subconjunctival hemorrhage, chemosis, subconjunctival air, wound suture

  3. anatomical success evaluation by optical coherence tomography and indirect ophthalmolscopy [post-op 3 month]

    whether the disease was successfully treated

  4. anatomical success evaluation by optical coherence tomography and indirect ophthalmolscopy [post-op 6 month]

    whether the disease was successfully treated

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT04902170
Other Study ID Numbers:
  • 202008057DIFD
First Posted:
May 26, 2021
Last Update Posted:
Nov 19, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by National Taiwan University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 19, 2021