Epiretinal Membrane, Macular Holes
Conditions
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).
Interventions
DEVICEInternal limiting membrane (ILM) Peeling with Sharkskin Forceps
25g Grieshaber Sharkskin ILM Forceps with Reflex Handle
DEVICEInternal limiting membrane (ILM) Peeling with Standard Forceps
25g Grieshaber Standard ILM Forceps
Sponsors
Sengi
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of attempts to initiate peeling | Surgery (Operative Visit) | Evaluated by recorded video |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of handle-ReSite/widefield viewing system lens touches | Surgery (Operative Visit) | Evaluated by recorded video |
| Duration of Peel | Surgery (Operative Visit) | Start to completion of peel |
| Number of deep retinal grasps | Surgery (Operative Visit) | Evaluated by recorded video |
Other
| Measure | Time frame |
|---|---|
| Corrected Distance Visual Acuity | 1 Month Postoperatively |
Countries
Canada
Contacts
Primary ContactBryon McKay, MD, PhD
Outcome results
None listed