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

56 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

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 data supports the effectiveness of the treatment Internal limiting membrane (ILM) Peeling for Macular Holes?

Research shows that peeling the internal limiting membrane (ILM) can improve the success rate of closing macular holes, which are small breaks in the central part of the retina. This treatment has been found effective in improving visual outcomes in macular hole surgeries. ^{1 2 3 4 5}

Is ILM peeling generally safe for humans?

ILM peeling is generally considered safe, but there are cases where it can cause retinal injury, which affects vision. Different types of forceps used in the procedure may have varying safety profiles. ^{1 2 4 5 6}

How is the treatment of ILM Peeling for Macular Holes unique?

ILM Peeling for Macular Holes is unique because it involves removing a thin layer of tissue from the eye's surface using specialized forceps, which can improve the success rate of closing the hole and may allow for a shorter recovery period with less time spent in a face-down position. ^{1 3 5 6 7}

Research Team

Bryon McKay, MD, PhD

Principal Investigator

UBC

Eligibility Criteria

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 have diabetic retinopathy.

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

I had a retinal detachment fixed with surgery or a gas bubble.

Timeline

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)

Treatment Details

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.

Participant Groups

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+

References

1. Japan pubmed.ncbi.nlm.nih.gov

[Visual outcome of macular hole surgery with internal limiting membrane peeling]. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

OUTER RETINAL INJURY SECONDARY TO MEMBRANE PEELING WITH INTERNAL LIMITING MEMBRANE FORCEPS. [2021]

3. France pubmed.ncbi.nlm.nih.gov

[Study of internal limiting membrane peeling in stage-3 and -4 idiopathic macular hole surgery]. [2006]

4. United States pubmed.ncbi.nlm.nih.gov

Efficiency and Safety of Internal Limiting Membrane Peeling with Different Forceps for Macular Disease. [2023]

5. India pubmed.ncbi.nlm.nih.gov

Internal limiting membrane peeling for large macular hole: Tailoring the rhexis to the shape of the hole. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Outcomes of macular hole surgery and shortened face down positioning. [2015]

7. Denmark pubmed.ncbi.nlm.nih.gov

Vitreous surgery combined with internal limiting membrane peeling for traumatic macular hole with severe retinal folds. [2019]