Comparison of Efficacy Between ILM Forceps
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19+
SponsorUniversity of British Columbia
About 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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Co-morbid diabetic retinopathy of any grade.
Neovascular AMD.
Previous vitrectomy.
Previous retinal detachment treated with scleral buckle or pneumatic retinopexy.
Trial design
Design model
Parallel
Treatments tested in this trial
Internal limiting membrane (ILM) Peeling with Sharkskin Forceps
Device25g Grieshaber Sharkskin ILM Forceps with Reflex Handle
Internal limiting membrane (ILM) Peeling with Standard Forceps
Device25g Grieshaber Standard ILM Forceps
Treatment groups
56 Participants
are divided into 2 treatment groupsGroup A: Sharkskin GroupExperimental treatment 1 intervention
Group B: Standard GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of attempts to initiate peeling
Evaluated by recorded video
Time frame
Surgery (Operative Visit)Secondary outcomes
1
Number of handle-ReSite/widefield viewing system lens touches
Evaluated by recorded video
Time frame
Surgery (Operative Visit)2
Duration of Peel
Start to completion of peel
Time frame
Surgery (Operative Visit)3
Number of deep retinal grasps
Evaluated by recorded video
Time frame
Surgery (Operative Visit)Other outcomes
1
Corrected Distance Visual Acuity
Time frame
1 Month PostoperativelySponsors and contacts
Click on the lead sponsor to view all of their trials.
University of British Columbia
Lead sponsor
Sengi
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: