ILM Peeling for Macular Holes

Overseen By Bryon McKay, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of British Columbia

Disqualifiers: Diabetic retinopathy, Neovascular AMD, Glaucoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best way to treat macular holes, which create a gap in the central part of the retina and can affect vision. Researchers compare two methods of a surgery called internal limiting membrane (ILM) peeling, using either standard forceps or a tool called Sharkskin forceps. The goal is to determine which method improves vision more effectively. Individuals with certain eye conditions, such as a macular hole or specific symptoms of an epiretinal membrane (a thin layer on the retina), might be suitable candidates for this trial. As a Phase 4 trial, this research involves an FDA-approved treatment and aims to understand how it can benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for the ILM Peeling treatments?

Research shows that using Sharkskin forceps for ILM (internal limiting membrane) peeling is safe. Studies indicate that this method carries a lower risk of complications for patients with various eye conditions. These forceps often outperform other tools, providing good results without causing additional harm.

Standard forceps for ILM peeling are also considered safe and have been a staple in eye surgeries for a long time. While some changes to the eye have been observed, they are generally not harmful.

Both treatments are well-tolerated, with few side effects reported, making them generally safe for most people. However, like any medical procedure, some risk exists. Participants should discuss these options with their doctors to determine the best approach for them. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the ILM peeling techniques for treating macular holes because they explore unique approaches to improving surgical outcomes. The Sharkskin Forceps offer a new, textured gripping surface, potentially allowing for more precise and controlled membrane removal compared to the standard ILM peeling methods. This could lead to better healing and visual recovery, which is why this technique is generating interest. Additionally, comparing these innovative forceps with the standard ones provides valuable insights into optimizing surgical techniques for eye health.

What evidence suggests that this trial's treatments could be effective for macular holes?

Research shows that peeling the internal limiting membrane (ILM) is a common procedure to treat macular holes. This trial will assign participants to different treatment arms to compare the effectiveness of ILM peeling using Sharkskin forceps versus standard forceps. Studies indicate that Sharkskin forceps make ILM peeling more efficient and lead to better results, with patients needing fewer attempts to start the peeling process. Standard forceps also effectively close macular holes in many cases, but they don't offer a clear advantage over other tools. Overall, ILM peeling increases the chances of a successful surgery for macular holes. ^{1 2 3 4 5}

Who Is on the Research Team?

Bryon McKay, MD, PhD

Principal Investigator

UBC

Are You a Good Fit for This Trial?

This trial is for individuals with macular pucker, retinal perforations, or macular holes. Participants should be suitable for surgery and able to attend follow-up appointments. Specific details on who can't join are not provided.

Inclusion Criteria

I am 19 or older and need surgery for my eye condition.

Exclusion Criteria

I am scheduled for or have had a combined cataract and vitrectomy surgery.

I have uncontrolled glaucoma or had surgery for it.

I have diabetic retinopathy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Assessment

Participants undergo pre-operative assessments including visual acuity and OCT measurements

1 week

1 visit (in-person)

Operative

Surgical procedure involving ILM peeling with either standard or Sharkskin forceps

1 day

1 visit (in-person)

Post-operative Follow-up

Participants are assessed for visual acuity and OCT at 1 month postoperatively

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Internal limiting membrane (ILM) Peeling with Sharkskin Forceps
• Internal limiting membrane (ILM) Peeling with Standard Forceps

Trial Overview The study compares two methods of peeling the internal limiting membrane (ILM) during eye surgery: using standard forceps versus sharkskin forceps. It's a randomized controlled trial observing outcomes pre-surgery, during surgery, and one month after.

How Is the Trial Designed?

Group I: Sharkskin Group Experimental Treatment 1 Intervention

25g Grieshaber Sharkskin ILM Forceps with Reflex Handle

Group II: Standard Group Active Control 1 Intervention

25g Grieshaber standard ILM

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Sengi

Industry Sponsor

Trials

28

Recruited

2,100+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38029422/

EFFICIENCY AND SAFETY OF INTERNAL LIMITING ... Conclusion: Sharkskin forceps provide better efficiency and outcome in ILM peeling in patients with various vitreomacular interface diseases, ...

2. journals.lww.com journals.lww.com/retinajournal/fulltext/2024/04000/efficiency_and_safety_of_internal_limiting.9.aspx

efficiency and safety of internal limiting membrane peeling . ... Sharkskin forceps provide better efficiency and outcome in ILM peeling in patients with various vitreomacular interface diseases.

3. link.springer.com link.springer.com/article/10.1007/s00417-022-05932-y

A randomised controlled trial evaluating internal limiting ... We conducted a masked proof-of concept randomised controlled trial (RCT) on 65 patients who underwent ILM peeling for idiopathic full-thickness macular hole ( ...

4. isrctn.com isrctn.com/ISRCTN70557873?q=&filters=&sort=&offset=7&totalResults=18541&page=1&pageSize=10&searchType=basic-search

A pilot randomised masked study of ILM peeling with the ... We propose a feasibility study to analyse the effects of ILM peeling in a pilot randomised controlled trial of 66 patients undergoing ILM peeling for macular ...

5. researchgate.net researchgate.net/publication/376044105_Efficiency_and_Safety_of_Internal_Limiting_Membrane_Peeling_with_Different_Forceps_for_Macular_Disease

Efficiency and Safety of Internal Limiting Membrane ... Results In the Sharkskin group, we demonstrated significantly fewer attempts to initiate ILM peeling compared with End-grasping group, with an ...