Comparison of Efficacy Between ILM Forceps

University of British Columbia

Status and phase: Not yet enrolling; Phase 4

Conditions: Macular Holes; Epiretinal Membrane

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06536569

H23-03318

Details and patient eligibility

About

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).

Enrollment: 56 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

• 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 design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

Sharkskin Group

Experimental group

Description:

25g Grieshaber Sharkskin ILM Forceps with Reflex Handle

Treatment:

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

Standard Group

Active Comparator group

Description:

25g Grieshaber standard ILM

Treatment:

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