Long-shaft Vitrectomy Probe in Highly Myopic Eyes

NCT04902170 | Completed

• 1 other identifier: 202008057DIFD
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Retinal Diseases; High Myopia

Keywords

High myopia; Pars plana vitrectomy; Vitreoretinal disease

Outcome Measures

Primary Outcomes (2)

• trocar removal rate

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

  intra-operative

• operation time

  record the operation time and time of core vitrectomy

  intra-operative

Secondary Outcomes (1)

• instrument bending

  intraoperative

Other Outcomes (4)

• Complications

  Until post-op 6 month

• wound status evaluation by slit lamp biomicroscopy

  until post-op 1 month

• anatomical success evaluation by optical coherence tomography and indirect ophthalmolscopy

  post-op 3 month

Study Arms (2)

study group

EXPERIMENTAL

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

control group

ACTIVE COMPARATOR

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

Interventions

25 gauge pars plana vitrectomy PROCEDURE

25 gauge pars plana vitrectomy

control group; study group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Retinal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Tzyy-Chang Ho

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2021
• First Posted: May 26, 2021
• Study Start: July 22, 2021
• Primary Completion: June 17, 2022
• Study Completion: February 7, 2023
• Last Updated: June 18, 2023

Record last verified: 2021-11

Locations

TW (1)