Pars Plana Vitrectomy With 25-gauge 20000 Cpm, Bevel-tip Cutter

Not Applicable

• Conditions: Dislocated Intraocular Lens Into Vitreous; Retained Lens Fragments; Vitreous Hemorrhage; Vitrectomy; Retinal Detachment; Macular Holes; Epiretinal Membrane
• Interventions: Device: 25-gauge, bevel-tip, 20000 cut per minute pars plana vitrectomy

• Registration Number: NCT04404296
• Lead Sponsor: Peregrine Eye and Laser Institute

Brief Summary

Report efficiency and clinical outcomes using 25-gauge, bevel-tip, 20000 cut per minute vitrectomy probe among eyes with various vitreo-retinal diseases

Detailed Description

We will evaluate the efficiency and clinical outcomes of pars plana vitrectomy using a 25-gauge, bevel-tip, 10 and 20000 cpm vitrectomy probe among eyes with 8 main surgical indications. Main outcome measures included efficiency measures, postoperative pain and complications.

Study Timeline

• Study First Submitted: 2020-04-20
• Study First Submitted QC: 2020-05-21
• Study First Posted: 2020-05-27
• Study Start: 2021-04-01
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-02
• Last Update Posted: 2021-06-04
• Primary Completion: 2021-10-30
• Study Completion: 2022-01-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• All eyes undergoing pars plana vitrectomy with surgically amenable vitreoretinal disease.

Exclusion Criteria

• History of prior PPV, glaucoma, scleral thinning, and active or recent history of (<3 months) ocular or extra-ocular infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
25-gauge 20000 PPV	25-gauge, bevel-tip, 20000 cut per minute pars plana vitrectomy	Eyes will undergo pars plana vitrectomy using 25-gauge, bevel-tip, 20000 cut per minute vitrectomy probe

Primary Outcome Measures

Name	Time	Method
Operative time: Total	6 months	From insertion of first trocar to removal of last trocar, measured in seconds using stopwatch

Secondary Outcome Measures

Name	Time	Method
Pain scoring	6 months	Visual Analogue scale (0 to 4)
Adverse events	Up to 3 months after surgery	Intra- and Postoperative complications
Number of times ancillary instruments placed in eye	6 months	Count

Trial Locations

Locations (1)

Peregrine Eye and Laser Instittute; 🇵🇭 Makati City, MM, Philippines