NCT04404296

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 27, 2020

Completed
10 months until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2022

Completed
Last Updated

June 4, 2021

Status Verified

June 1, 2021

Enrollment Period

7 months

First QC Date

April 20, 2020

Last Update Submit

June 2, 2021

Conditions

VitrectomyRetinal DetachmentVitreous HemorrhageMacular HolesEpiretinal MembraneDislocated Intraocular Lens Into VitreousRetained Lens Fragments

Keywords

Small gauge vitrectomy probe20000 cut per minuteMicroincisional vitrectomy system

Outcome Measures

Primary Outcomes (1)

  • Operative time: Total

    From insertion of first trocar to removal of last trocar, measured in seconds using stopwatch

    6 months

Secondary Outcomes (3)

  • Pain scoring

    6 months

  • Adverse events

    Up to 3 months after surgery

  • Number of times ancillary instruments placed in eye

    6 months

Study Arms (1)

25-gauge 20000 PPV

OTHER

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

Device: 25-gauge, bevel-tip, 20000 cut per minute pars plana vitrectomy

Interventions

25-gauge, bevel-tip, 20000 cut per minute pars plana vitrectomyDEVICE

Pars plana vitrectomy using 25-gauge, bevel-tip, 20000 cut per minute vitrectomy probe

25-gauge 20000 PPV

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peregrine Eye and Laser Instittute

Makati City, MM, 1209, Philippines

RECRUITING

MeSH Terms

Conditions

Retinal DetachmentVitreous HemorrhageRetinal PerforationsEpiretinal Membrane

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesEye HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Harvey S Uy, MD

    Peregrine Eye and Laser Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Harvey S Uy, MD

CONTACT

639175239332harveyuy@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Interventional case series
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director

Study Record Dates

First Submitted

April 20, 2020

First Posted

May 27, 2020

Study Start

April 1, 2021

Primary Completion

October 30, 2021

Study Completion

January 30, 2022

Last Updated

June 4, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

PH(1)