Comparison of Efficacy Between ILM Forceps

NCT ID: NCT06536569

Last Updated: 2025-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2026-01-01

Brief Summary

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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

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Conditions

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Macular Holes Epiretinal Membrane

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Sharkskin Group

25g Grieshaber Sharkskin ILM Forceps with Reflex Handle

Group Type EXPERIMENTAL

Internal limiting membrane (ILM) Peeling with Sharkskin Forceps

Intervention Type DEVICE

25g Grieshaber Sharkskin ILM Forceps with Reflex Handle

Standard Group

25g Grieshaber standard ILM

Group Type ACTIVE_COMPARATOR

Internal limiting membrane (ILM) Peeling with Standard Forceps

Intervention Type DEVICE

25g Grieshaber Standard ILM Forceps

Interventions

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Internal limiting membrane (ILM) Peeling with Sharkskin Forceps

25g Grieshaber Sharkskin ILM Forceps with Reflex Handle

Intervention Type DEVICE

Internal limiting membrane (ILM) Peeling with Standard Forceps

25g Grieshaber Standard ILM Forceps

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sengi

INDUSTRY

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Bryon McKay

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bryon McKay, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UBC

Locations

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Department of Ophthalmology & Visual Sciences, St Paul's Hospital, Ophthalmology

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

Central Contacts

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Bryon McKay, MD, PhD

Role: CONTACT

604 806 9090

Facility Contacts

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Bryon McKay, MD, PhD

Role: primary

604 806 9090

Other Identifiers

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H23-03318

Identifier Type: -

Identifier Source: org_study_id

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