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Not yet recruitingNCT06536569Updated Mar 30, 2025

Comparison of Efficacy Between ILM Forceps

A Phase 4 interventional study of Internal limiting membrane (ILM) Peeling with Sharkskin Forceps and Internal limiting membrane (ILM) Peeling with Standard Forceps in Macular Holes and Epiretinal Membrane, sponsored by University of British Columbia. Not yet recruiting at 1 site in Canada. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2025-03-30.

Sponsored by University of British Columbia · Phase 4, Interventional, and Basic science

From the registry’s dates

  • Primary completion was expected by Dec 2025, 11 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 4
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Macular Holes
  • Epiretinal Membrane
03

In context

Retinal Perforations

139 studies on the registry are indexed under Retinal Perforations; 22 are open to participants now.

This study's planned enrollment of 56 is above the median of 50 across 94 interventional studies indexed under Retinal Perforations.

Browse Retinal Perforations studies →

Lead sponsor

University of British Columbia is the lead sponsor of 1,339 studies on the registry; 259 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
56 participants (estimated)

Study arms

  • Experimental
    Sharkskin Group

    25g Grieshaber Sharkskin ILM Forceps with Reflex Handle

    Device: Internal limiting membrane (ILM) Peeling with Sharkskin Forceps

  • Active comparator
    Standard Group

    25g Grieshaber standard ILM

    Device: Internal limiting membrane (ILM) Peeling with Standard Forceps

Interventions

  • DeviceInternal limiting membrane (ILM) Peeling with Sharkskin Forceps

    25g Grieshaber Sharkskin ILM Forceps with Reflex Handle

  • DeviceInternal limiting membrane (ILM) Peeling with Standard Forceps

    25g Grieshaber Standard ILM Forceps

06

What researchers measure

Primary outcomes

  1. Number of attempts to initiate peeling

    Evaluated by recorded video

    Time frame: Surgery (Operative Visit)

Secondary outcomes

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

    Evaluated by recorded video

    Time frame: Surgery (Operative Visit)

  2. Duration of Peel

    Start to completion of peel

    Time frame: Surgery (Operative Visit)

  3. Number of deep retinal grasps

    Evaluated by recorded video

    Time frame: Surgery (Operative Visit)

Other outcomes

  1. Corrected Distance Visual Acuity

    Time frame: 1 Month Postoperatively

07

Study locations

1 site
  • Department of Ophthalmology & Visual Sciences, St Paul's Hospital, Ophthalmology
    Vancouver, British Columbia V6Z 1Y6, Canada
    • Bryon McKay, MD, PhD · Contactmckaybr.phd@gmail.com · 604 806 9090
    • Bryon McKay, MD, PhD · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jul 2025; primary completion for Dec 2025, 5 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 22, 2024
First posted
Aug 5, 2024
StartEst.
Jul 1, 2025
Primary completionEst.
Dec 1, 2025
CompletionEst.
Jan 1, 2026
Last update
Mar 30, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06536569
Collaborators
Sengi
Responsible party
Bryon McKay (Principal Investigator, University of British Columbia) — Principal investigator
First posted
Aug 5, 2024
Start date
Jul 1, 2025 (estimated)
Primary completion
Dec 1, 2025 (estimated)
Completion
Jan 1, 2026 (estimated)
Last update
Mar 30, 2025

Study contacts

Bryon McKay, MD, PhD
Contact
mckaybr.phd@gmail.com
604 806 9090
Bryon McKay, MD, PhD
principal investigator · UBC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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