Comparison of Efficacy Between ILM Forceps | NCT06536569

Studies
Comparison of Efficacy Between ILM Forceps

NCT06536569

Sponsor

University of British Columbia

Status

Not yet recruiting

Last Update Posted

Mar 30, 2025Actual

Enrollment

56Estimated

Phase

Phase 4

Conditions

Macular Holes
Epiretinal Membrane

Interventions

Internal limiting membrane (ILM) Peeling with Sharkskin Forceps
Internal limiting membrane (ILM) Peeling with Standard Forceps

Countries

Canada

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

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2025Estimated

Primary Completion Date

Dec 1, 2025Estimated

Completion Date

Jan 1, 2026Estimated

First Submitted Date

Jul 22, 2024

First Submission Date that Met QC Criteria

Jul 30, 2024

First Posted Date

Aug 5, 2024Actual

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

Mar 25, 2025

Last Update Posted Date

Mar 30, 2025Actual

Name	Class
Sengi	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

This study is a Single center, prospective, observational, multi surgeon randomized controlled trial. Subjects will be assessed pre-operatively, operatively and at 1 month postoperatively. Clinical evaluations will include measurement of visual acuity and optical coherence tomography (OCT).

Detailed Description

Not provided

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

56Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sharkskin Group	Experimental	25g Grieshaber Sharkskin ILM Forceps with Reflex Handle	Device: Internal limiting membrane (ILM) Peeling with Sharkskin Forceps
Standard Group	Active Comparator	25g Grieshaber standard ILM	Device: Internal limiting membrane (ILM) Peeling with Standard Forceps

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Internal limiting membrane (ILM) Peeling with Sharkskin Forceps	Device	25g Grieshaber Sharkskin ILM Forceps with Reflex Handle	Sharkskin Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of attempts to initiate peeling	Evaluated by recorded video	Surgery (Operative Visit)

Secondary Outcomes

Measure	Description	Time Frame
Number of handle-ReSite/widefield viewing system lens touches	Evaluated by recorded video	Surgery (Operative Visit)
Duration of Peel	Start to completion of peel

Other Outcomes

Measure	Description	Time Frame
Corrected Distance Visual Acuity		1 Month Postoperatively

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

• 19y and older patients with symptomatic ERM (grade 2-3) or Macular hole (non flap-requiring) for elective ILM peeling surgery.

Exclusion Criteria:

Co-morbid diabetic retinopathy of any grade.
Neovascular AMD.
Previous vitrectomy.
Previous retinal detachment treated with scleral buckle or pneumatic retinopexy.
Uncontrolled glaucoma or previous glaucoma surgery.
Combined phacovitrectomy.
Macula holes with severity requiring flap.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 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
Bryon McKay, MD, PhD	Contact	604 806 9090		mckaybr.phd@gmail.com

Overall Officials

Name	Affiliation	Role
Bryon McKay, MD, PhD	UBC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Ophthalmology & Visual Sciences, St Paul's Hospital, Ophthalmology		Vancouver	British Columbia	V6Z 1Y6	Canada

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

Condition Browse Module

MeSH Terms

ID	Term
D012167	Retinal Perforations
D019773	Epiretinal Membrane

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014894	Weights and Measures

Ancestor Terms

ID	Term
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided