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NCT Number: NCT06536569

Comparison of Efficacy Between ILM Forceps

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).

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Key information

Conditions

Macular Holes Epiretinal Membrane Eye Diseases Retinal Diseases Retinal Perforations

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Vancouver, British Columbia, V6Z 1Y6, Canada

Location contact

Bryon McKay, MD, PhD

CONTACT

[email protected]

604 806 9090

Bryon McKay, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Internal limiting membrane (ILM) Peeling with Sharkskin Forceps

Device

25g Grieshaber Sharkskin ILM Forceps with Reflex Handle

Internal limiting membrane (ILM) Peeling with Standard Forceps

Device

25g Grieshaber Standard ILM Forceps

Primary outcomes

  1. Number of attempts to initiate peeling

    Time frame: Surgery (Operative Visit)

    Evaluated by recorded video

Secondary outcomes

  1. Number of handle-ReSite/widefield viewing system lens touches

    Time frame: Surgery (Operative Visit)

    Evaluated by recorded video

  2. Duration of Peel

    Time frame: Surgery (Operative Visit)

    Start to completion of peel

  3. Number of deep retinal grasps

    Time frame: Surgery (Operative Visit)

    Evaluated by recorded video

Other outcomes

  1. Corrected Distance Visual Acuity

    Time frame: 1 Month Postoperatively

Study contacts

Contact information is provided by the study sponsor or research team.

Bryon McKay, MD, PhD

CONTACT

[email protected]

604 806 9090

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Sengi

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Aug 5, 2024
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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