Comparison of Efficacy Between ILM Forceps

March 25, 2025 updated by: Bryon McKay, University of British Columbia

A Comparison of the Efficacy of 25g Grieshaber Sharkskin ILM Forceps with Reflex Handle Vs Standard 25g Grieshaber ILM Forceps for Internal Limiting Membrane Peeling

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

56

Phase

  • Phase 4

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

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • Department of Ophthalmology & Visual Sciences, St Paul's Hospital, Ophthalmology
        • Contact:
        • Contact:
          • Bryon McKay, MD, PhD

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sharkskin Group
25g Grieshaber Sharkskin ILM Forceps with Reflex Handle
Device: Internal limiting membrane (ILM) Peeling with Sharkskin Forceps
25g Grieshaber Sharkskin ILM Forceps with Reflex Handle
Active Comparator: Standard Group
25g Grieshaber standard ILM
Device: Internal limiting membrane (ILM) Peeling with Standard Forceps
25g Grieshaber Standard ILM Forceps

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
Corrected Distance Visual Acuity
Time Frame: 1 Month Postoperatively
1 Month Postoperatively

Collaborators and Investigators

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

Sponsor

University of British Columbia

Collaborators

Sengi

Investigators

  • Principal Investigator: Bryon McKay, MD, PhD, UBC

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 (Estimated)

July 1, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

July 22, 2024

First Submitted That Met QC Criteria

July 30, 2024

First Posted (Actual)

August 5, 2024

Study Record Updates

Last Update Posted (Actual)

March 30, 2025

Last Update Submitted That Met QC Criteria

March 25, 2025

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H23-03318

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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