Pars Plana Vitrectomy With 25-gauge 20000 Cpm, Bevel-tip... | NCT04404296

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

NCT04404296

Sponsor

Peregrine Eye and Laser Institute

Status

Unknown status

Last Update Posted

Jun 4, 2021Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Vitrectomy
Retinal Detachment
Vitreous Hemorrhage
Macular Holes
Epiretinal Membrane
Dislocated Intraocular Lens Into Vitreous
Retained Lens Fragments

Interventions

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

Countries

Philippines

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2021Actual

Primary Completion Date

Oct 30, 2021Estimated

Completion Date

Jan 30, 2022Estimated

First Submitted Date

Apr 20, 2020

First Submission Date that Met QC Criteria

May 21, 2020

First Posted Date

May 27, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 2, 2021

Last Update Posted Date

Jun 4, 2021Actual

Name	Class
Alcon Research	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
25-gauge, bevel-tip, 20000 cut per minute pars plana vitrectomy	Device	Pars plana vitrectomy using 25-gauge, bevel-tip, 20000 cut per minute vitrectomy probe	25-gauge 20000 PPV

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Pain scoring	Visual Analogue scale (0 to 4)	6 months
Adverse events	Intra- and Postoperative complications	Up to 3 months after surgery

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Harvey S Uy, MD	Contact	639175239332		harveyuy@yahoo.com

Overall Officials

Name	Affiliation	Role
Harvey S Uy, MD	Peregrine Eye and Laser Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peregrine Eye and Laser Instittute	Recruiting	Makati City	MM	1209	Philippines

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases
D005130	Eye Hemorrhage
D006470	Hemorrhage
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D012163	Retinal Detachment
D014823	Vitreous Hemorrhage
D012167	Retinal Perforations
D019773	Epiretinal Membrane