Instrument Tissue Interaction at the Grasp Site During Membrane Peeling of Epiretinal Membranes (NCT06459284) | Clinical Trial Compass
CompletedNot Applicable
Instrument Tissue Interaction at the Grasp Site During Membrane Peeling of Epiretinal Membranes
Austria55 participantsStarted 2024-06-03
Plain-language summary
Epiretinal membranes are a disease of the retinal surface, that may affect visual acuity and cause metamorphopsia. Using vitrectomy with membrane peeling, postoperative improvement of visual acuity and metamorphopsia may be achieved in a majority of patients. Diaz et al. demonstrated that there are postoperative changes in the "nerve fiber layer" after ILM peeling, but in that study, no recording of instrument/tissue interactions was performed using iOCT.
The aim of this study is to examine dipping into retinal tissue with the forceps during grasping of the epiretinal membrane at the starting point of peeling with iOCT.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Vitrectomy with membrane peeling with iOCT assistance due to an ERM in the time-period from 1.6.2014 to 31.12.2016 (early phase) or 1.11.2020 to 31.7.2022.
* Age 18 and older
Exclusion Criteria:
* iOCT was not used during surgery
* bad image quality, excluding analysis of images
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
occurrence of dipping into retinal tissue with the ILM forceps during grasping
Timeframe: during surgery, an average of 30 minutes
2
amount of dipping into retinal tissue with the ILM forceps during grasping, measured with ImageJ
Timeframe: during surgery, an average of 30 minutes