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

Primary Purpose

Vitrectomy, Retinal Detachment, Vitreous Hemorrhage

Status
Unknown status
Phase
Not Applicable
Locations
Philippines
Study Type
Interventional
Intervention
25-gauge, bevel-tip, 20000 cut per minute pars plana vitrectomy
Sponsored by
Peregrine Eye and Laser Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitrectomy focused on measuring Small gauge vitrectomy probe, 20000 cut per minute, Microincisional vitrectomy system

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peregrine Eye and Laser InstittuteRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

25-gauge 20000 PPV

Arm Description

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

Outcomes

Primary Outcome Measures

Operative time: Total
From insertion of first trocar to removal of last trocar, measured in seconds using stopwatch

Secondary Outcome Measures

Pain scoring
Visual Analogue scale (0 to 4)
Adverse events
Intra- and Postoperative complications
Number of times ancillary instruments placed in eye
Count

Full Information

First Posted
April 20, 2020
Last Updated
June 2, 2021
Sponsor
Peregrine Eye and Laser Institute
Collaborators
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT04404296
Brief Title
Pars Plana Vitrectomy With 25-gauge 20000 Cpm, Bevel-tip Cutter
Acronym
HYPE
Official Title
Efficiency and Clinical Outcomes of 25-gauge, Bevel-tip, 20000 Cuts-per-minute, Pars Plana Vitrectomy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
October 30, 2021 (Anticipated)
Study Completion Date
January 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peregrine Eye and Laser Institute
Collaborators
Alcon Research

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitrectomy, Retinal Detachment, Vitreous Hemorrhage, Macular Holes, Epiretinal Membrane, Dislocated Intraocular Lens Into Vitreous, Retained Lens Fragments
Keywords
Small gauge vitrectomy probe, 20000 cut per minute, Microincisional vitrectomy system

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Interventional case series
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
25-gauge 20000 PPV
Arm Type
Other
Arm Description
Eyes will undergo pars plana vitrectomy using 25-gauge, bevel-tip, 20000 cut per minute vitrectomy probe
Intervention Type
Device
Intervention Name(s)
25-gauge, bevel-tip, 20000 cut per minute pars plana vitrectomy
Intervention Description
Pars plana vitrectomy using 25-gauge, bevel-tip, 20000 cut per minute vitrectomy probe
Primary Outcome Measure Information:
Title
Operative time: Total
Description
From insertion of first trocar to removal of last trocar, measured in seconds using stopwatch
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Pain scoring
Description
Visual Analogue scale (0 to 4)
Time Frame
6 months
Title
Adverse events
Description
Intra- and Postoperative complications
Time Frame
Up to 3 months after surgery
Title
Number of times ancillary instruments placed in eye
Description
Count
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Harvey S Uy, MD
Phone
639175239332
Email
harveyuy@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harvey S Uy, MD
Organizational Affiliation
Peregrine Eye and Laser Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peregrine Eye and Laser Instittute
City
Makati City
State/Province
MM
ZIP/Postal Code
1209
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rheamel Navarro
Phone
+63288900115
Email
rheanavarro82@gmail.com
First Name & Middle Initial & Last Name & Degree
Pik Sha Chan, MD
First Name & Middle Initial & Last Name & Degree
Jordan Famadico, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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