Long-shaft Vitrectomy Probe in Highly Myopic Eyes

Not Applicable

Completed

• Conditions: Retinal Diseases; High Myopia
• Interventions: Procedure: 25 gauge pars plana vitrectomy

• Registration Number: NCT04902170
• Lead Sponsor: National Taiwan University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-21
• Study First Submitted QC: 2021-05-20
• Study First Posted: 2021-05-26
• Study Start: 2021-07-22
• Status Verified: 2021-11
• Primary Completion: 2022-06-17
• Study Completion: 2023-02-07
• Last Update Submitted: 2023-06-14
• Last Update Posted: 2023-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	25 gauge pars plana vitrectomy	Highly myopic patients with vitreoretinal disease requiring pars plana vitrectomy. The 27mm (shaft length) vitrectomy probe (25 gauge) would be used in the surgery.
study group	25 gauge pars plana vitrectomy	Highly myopic patients with vitreoretinal disease requiring pars plana vitrectomy. The 30mm (shaft length) vitrectomy probe (25 gauge) would be used in the surgery.

Primary Outcome Measures

Name	Time	Method
operation time	intra-operative	record the operation time and time of core vitrectomy
trocar removal rate	intra-operative	trocar removal would be performed if the length of vitrectomy probe was not adequate

Secondary Outcome Measures

Name	Time	Method
instrument bending	intraoperative	record the occurrence of instrument bending

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan