Comparison of Efficacy Between ILM Forceps
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
1 other identifier
interventional
56
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jul 2025
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2024
CompletedFirst Posted
Study publicly available on registry
August 5, 2024
CompletedStudy Start
First participant enrolled
July 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2026
CompletedMarch 30, 2025
July 1, 2024
5 months
July 22, 2024
March 25, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Number of attempts to initiate peeling
Evaluated by recorded video
Surgery (Operative Visit)
Secondary Outcomes (3)
Number of handle-ReSite/widefield viewing system lens touches
Surgery (Operative Visit)
Duration of Peel
Surgery (Operative Visit)
Number of deep retinal grasps
Surgery (Operative Visit)
Other Outcomes (1)
Corrected Distance Visual Acuity
1 Month Postoperatively
Study Arms (2)
Sharkskin Group
EXPERIMENTAL25g Grieshaber Sharkskin ILM Forceps with Reflex Handle
Standard Group
ACTIVE COMPARATOR25g Grieshaber standard ILM
Interventions
25g Grieshaber Sharkskin ILM Forceps with Reflex Handle
25g Grieshaber Standard ILM Forceps
Eligibility Criteria
You may qualify if:
- 19y and older patients with symptomatic ERM (grade 2-3) or Macular hole (non flap-requiring) for elective ILM peeling surgery.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of British Columbialead
- Sengicollaborator
Study Sites (1)
Department of Ophthalmology & Visual Sciences, St Paul's Hospital, Ophthalmology
Vancouver, British Columbia, V6Z 1Y6, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bryon McKay, MD, PhD
UBC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 22, 2024
First Posted
August 5, 2024
Study Start
July 1, 2025
Primary Completion
December 1, 2025
Study Completion
January 1, 2026
Last Updated
March 30, 2025
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share