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NCT04404296 Clinical Trial

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

Retinal Detachment Clinical Trial

— HYPE  

Official title:
Efficiency and Clinical Outcomes of 25-gauge, Bevel-tip, 20000 Cuts-per-minute, Pars Plana Vitrectomy

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04404296
Other study ID # 20190101
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 1, 2021
Est. completion date January 30, 2022

Study information
Verified date June 2021
Source Peregrine Eye and Laser Institute
Contact Harvey S Uy, MD
Phone 639175239332
Email harveyuy@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date January 30, 2022
Est. primary completion date October 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• 25-gauge, bevel-tip, 20000 cut per minute pars plana vitrectomy
Pars plana vitrectomy using 25-gauge, bevel-tip, 20000 cut per minute vitrectomy probe

Locations
Country Name City State
Philippines Peregrine Eye and Laser Instittute Makati City MM

Sponsors (2)
Lead Sponsor Collaborator
Peregrine Eye and Laser Institute Alcon Research

Country where clinical trial is conducted

Philippines, 

Outcome
Type Measure Description Time frame Safety issue
Primary Operative time: Total From insertion of first trocar to removal of last trocar, measured in seconds using stopwatch 6 months
Secondary Pain scoring Visual Analogue scale (0 to 4) 6 months
Secondary Adverse events Intra- and Postoperative complications Up to 3 months after surgery
Secondary Number of times ancillary instruments placed in eye Count 6 months
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