Macular HolesPhase 4NCT06536569
Comparison of Efficacy Between ILM Forceps
A Phase 4 study testing Internal limiting membrane (ILM) Peeling with Sharkskin Forceps and Internal limiting membrane (ILM) Peeling with Standard Forceps in people with Macular Holes and Epiretinal Membrane, run by University of British Columbia at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Macular Holes, Epiretinal Membrane
- What is being tested?
- Internal limiting membrane (ILM) Peeling with Sharkskin Forceps and Internal limiting membrane (ILM) Peeling with Standard Forceps
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2025to 1 Jan 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 19y and older patients with symptomatic ERM (grade 2-3) or Macular hole (non flap-requiring) for elective ILM peeling surgery.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Department of Ophthalmology & Visual Sciences, St Paul's Hospital, Ophthalmology
Vancouver, British Columbia, V6Z 1Y6
Bryon McKay, MD, PhD, 604 806 9090, mckaybr.phd@gmail.com
Bryon McKay, MD, PhD
About this study
Official 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
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).
- Conditions
- Macular Holes, Epiretinal Membrane
- Being tested
- Internal limiting membrane (ILM) Peeling with Sharkskin Forceps, Internal limiting membrane (ILM) Peeling with Standard Forceps
- Medical subject headings
- Retinal Perforations, Epiretinal Membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internal limiting membrane (ILM) Peeling with Sharkskin ForcepsDevice
25g Grieshaber Sharkskin ILM Forceps with Reflex Handle
Internal limiting membrane (ILM) Peeling with Standard ForcepsDevice
25g Grieshaber Standard ILM Forceps
| Study group | Role | What they receive |
|---|---|---|
| Sharkskin Group | Experimental | 25g Grieshaber Sharkskin ILM Forceps with Reflex Handle Receives: Device: Internal limiting membrane (ILM) Peeling with Sharkskin Forceps |
| Standard Group | Active comparator | 25g Grieshaber standard ILM Receives: Device: Internal limiting membrane (ILM) Peeling with Standard Forceps |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of attempts to initiate peeling
Evaluated by recorded video
Measured: Surgery (Operative Visit)
Secondary outcomes (3)
Number of handle-ReSite/widefield viewing system lens touches
Evaluated by recorded video
Measured: Surgery (Operative Visit)
Duration of Peel
Start to completion of peel
Measured: Surgery (Operative Visit)
Number of deep retinal grasps
Evaluated by recorded video
Measured: Surgery (Operative Visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start1 Jul 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular HolesStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Sengi
- Responsible party
- Principal investigator, Bryon McKay, University of British Columbia
- Investigators
- Bryon McKay, MD, PhD, Principal investigator, UBC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06536569
- Sponsor's protocol ID
- H23-03318
- Status last verified
- Jul 2024
- First submitted
- 22 Jul 2024
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06536569
- Acronym / sponsor ID
- H23-03318
- Conditions
- Macular Holes, Epiretinal Membrane
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Sengi
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 5 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sharkskin Group | Experimental | Device: Internal limiting membrane (ILM) Peeling with Sharkskin Forceps25g Grieshaber Sharkskin ILM Forceps with Reflex Handle |
| Standard Group | Active comparator | Device: Internal limiting membrane (ILM) Peeling with Standard Forceps25g Grieshaber standard ILM |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 19y and older patients with symptomatic ERM (grade 2-3) or Macular hole (non flap-requiring) for elective ILM peeling surgery.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internal limiting membrane (ILM) Peeling with Sharkskin Forceps25g Grieshaber Sharkskin ILM Forceps with Reflex Handle | Device | Sharkskin Group |
| Internal limiting membrane (ILM) Peeling with Standard Forceps25g Grieshaber Standard ILM Forceps | Device | Standard Group |
Primary outcome
Number of attempts to initiate peeling
Time frame: Surgery (Operative Visit)
Evaluated by recorded video
3 secondary outcomes
Number of handle-ReSite/widefield viewing system lens touches
Time frame: Surgery (Operative Visit)
Duration of Peel
Time frame: Surgery (Operative Visit)
Number of deep retinal grasps
Time frame: Surgery (Operative Visit)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Macular Holes
RecruitingObservational study
Intraoperative OCT Guidance of Intraocular Surgery II
Macular Holes, Epiretinal Membrane
Recruiting
Autologous Tenon's Capsule Graft for Refractory Macular Holes
Macular Hole Surgery
Active, not recruiting
Outcomes of Macular Hole Surgery With Inverted Flap With vs Without Post op Posturing With SF6 in Macular Hole More Than 400 Micrometres
Macular Hole
Recruiting
Comparative Study of Decellularized Human Amniotic Membrane Hydrogel and Inverted Internal Limiting Membrane Flap in Idiopathic Large Macular Holes
Macular Holes
RecruitingObservational study
Surgical Procedure Efficiency Evaluation stuDy
Cataract, Vitreous Hemorrhage
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bryon McKay, MD, PhD principal investigator
UBC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Internal limiting membrane (ILM) Peeling with Sharkskin Forceps and Internal limiting membrane (ILM) Peeling with Standard Forceps in people with Macular Holes and Epiretinal Membrane, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bryon McKay, MD, PhD (604 806 9090, mckaybr.phd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of attempts to initiate peeling (time frame: Surgery (Operative Visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025; AzTrials last refreshed its copy on 26 Oct 2026.