Comparison of Efficacy Between ILM Forceps
Phase 4
Not yet recruiting
- Conditions
- Macular HolesEpiretinal Membrane
- Registration Number
- NCT06536569
- Lead Sponsor
- University of British Columbia
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 56
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Number of attempts to initiate peeling Surgery (Operative Visit) Evaluated by recorded video
- Secondary Outcome Measures
Name Time Method Number of deep retinal grasps Surgery (Operative Visit) Evaluated by recorded video
Duration of Peel Surgery (Operative Visit) Start to completion of peel
Number of handle-ReSite/widefield viewing system lens touches Surgery (Operative Visit) Evaluated by recorded video
Trial Locations
- Locations (1)
Department of Ophthalmology & Visual Sciences, St Paul's Hospital, Ophthalmology
🇨🇦Vancouver, British Columbia, Canada
Department of Ophthalmology & Visual Sciences, St Paul's Hospital, Ophthalmology🇨🇦Vancouver, British Columbia, CanadaBryon McKay, MD, PhDContact