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

June 2, 2021 updated by: Harvey Siy Uy, Peregrine Eye and Laser Institute

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Philippines
    • MM
      • Makati City, MM, Philippines, 1209
        • Recruiting
        • Peregrine Eye and Laser Instittute
        • Contact:
        • Sub-Investigator:
          • Pik Sha Chan, MD
        • Sub-Investigator:
          • Jordan Famadico, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 25-gauge 20000 PPV
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
Pars plana vitrectomy using 25-gauge, bevel-tip, 20000 cut per minute vitrectomy probe

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative time: Total
Time Frame: 6 months
From insertion of first trocar to removal of last trocar, measured in seconds using stopwatch
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peregrine Eye and Laser Institute

Collaborators

Alcon Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Anticipated)

October 30, 2021

Study Completion (Anticipated)

January 30, 2022

Study Registration Dates

First Submitted

April 20, 2020

First Submitted That Met QC Criteria

May 21, 2020

First Posted (Actual)

May 27, 2020

Study Record Updates

Last Update Posted (Actual)

June 4, 2021

Last Update Submitted That Met QC Criteria

June 2, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20190101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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