Comparison of Efficacy Between ILM Forceps

Phase 4Not Yet RecruitingNCT06536569

University of British Columbia56 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Macular Holes Epiretinal Membrane

Interventions

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

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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.

Locations (1)

Department of Ophthalmology & Visual Sciences, St Paul's Hospital, Ophthalmology

Vancouver, British Columbia, Canada

Outcomes

Primary Outcomes

Number of attempts to initiate peeling

Evaluated by recorded video

Time frame: Surgery (Operative Visit)

Secondary Outcomes

Number of handle-ReSite/widefield viewing system lens touches

Evaluated by recorded video

Time frame: Surgery (Operative Visit)

Duration of Peel

Start to completion of peel

Time frame: Surgery (Operative Visit)

Number of deep retinal grasps

Evaluated by recorded video

Time frame: Surgery (Operative Visit)

Central Contacts

Bryon McKay, MD, PhD

CONTACT

604 806 9090 mckaybr.phd@gmail.com

Data from ClinicalTrials.gov

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