Long-shaft Vitrectomy Probe in Highly Myopic Eyes

NCT ID: NCT04902170

Last Updated: 2023-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-22

Study Completion Date

2023-02-07

Brief Summary

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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

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Conditions

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Retinal Diseases High Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

25 gauge pars plana vitrectomy

Intervention Type PROCEDURE

25 gauge pars plana vitrectomy

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.

Group Type ACTIVE_COMPARATOR

25 gauge pars plana vitrectomy

Intervention Type PROCEDURE

25 gauge pars plana vitrectomy

Interventions

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25 gauge pars plana vitrectomy

25 gauge pars plana vitrectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tzyy-Chang Ho

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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202008057DIFD

Identifier Type: -

Identifier Source: org_study_id

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