An observational study in Epiretinal Membrane, sponsored by Nantes University Hospital. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-09.
Sponsored by Nantes University Hospital · Observational
Epiretinal membrane (ERM) is a pathological phenomenon requiring surgery when vision is altered.
ERM surgery requires ERM peeling, then active internal limiting membrane (ILM) peeling if it is not spontaneously peeled with ERM. Initiation of peeling is very delicate and can lead to micro scotoma when realized with microscopic forceps. The Sweeper is a microscopic tool with a soft silicon tip covered with diamond dust which allows peeling initiation without retina prehension. It may reduce retinal trauma and visual sequelae.
Purpose of our study is to evaluate use of sweeper during 20 ERM surgeries. The investigator will compare microperimetry before surgery versus those after 1 month (M1) and 3 months (M3), and measure difference of number and depths of micro scotoma.
The investigator will note: number of forceps uses if sweeper is inefficient and all areas of sweeper use to correlate them with micro scotoma.
The investigator will evaluate visual and optical coherence tomography improvement after surgery.
Epiretinal membrane (ERM) is a pathological phenomenon that leads to visual loss, visual distortions, central scotoma, and diplopia. No medical treatment is yet available.
ERM surgery requires separation of normal retina and epiretinal membrane. After epiretinal peeling, if internal limiting membrane (ILM) is not spontaneously peeled with ERM, surgeon peels ILM from retina (also named active peeling). Initiation of peeling is very accurate and delicate. Either microscopic forceps or sweeper are used to initiate peeling. Sweeper is a microscopic tool with a soft silicon tip covered with diamond dust which allows peeling initiation without retina prehension. It may reduce retinal trauma and visual sequelae.
ILM active peeling reduces recurrence of ERM and rate of repeat surgery. No visual acuity loss has been found. But 2 studies show increase of micro scotoma at micro-perimetry after active ILM peeling with forceps.
Purpose of our study is to evaluate use of sweeper during 20 ERM surgeries. The investigator will compare microperimetry before surgery versus those after 1 month (M1) and 3 months (M3), and measure difference of number and depths of micro scotoma.
The investigator will note: number of forceps uses if sweeper is inefficient, all areas of sweeper use to correlate them with micro scotoma.
The investigator will evaluate visual and optical coherence tomography improvement after surgery.
Our study doesn't include any intervention while surgeries would be realized with or without study participation. Examinations are non-invasive, usual, and done during usual medical visit without additional visit.
130 studies on the registry are indexed under Epiretinal Membrane; 18 are open to participants now.
This study's enrollment of 9 is below the median of 60 across 48 observational studies indexed under Epiretinal Membrane.
Browse Epiretinal Membrane studies →Nantes University Hospital is the lead sponsor of 839 studies on the registry; 195 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The population concerned corresponds to the major patients consulting in the ophthalmology department at the Nantes University Hospital and presenting an epiretinal membrane and an operative indication.
Patients will be included at the epiretinal membrane surgery programming consultation. No inclusion will be made as part of the emergency.
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Exclusion Criteria:
Non interventional study (collect of data)
Difference of number and depth of micro scotoma before and after epiretinal membrane (ERM) surgery with sweeper
Time frame: microperimetry at baseline, then 1 month after surgery (M1), then 3 months after (M3)
Efficacy of sweeper mesured by number of forceps uses if sweeper is inefficient
Time frame: Day of surgery
Visual improvement measured by visual acuity and optical coherence tomography improvement after surgery , visual acuity and OCT morphometry before surgery, M1 and M3
Time frame: at baseline, then 1 month after surgery (M1), then 3 months after (M3)
Optical coherence tomography (OCT) improvement after surgery measured by OCT morphometry
Time frame: at baseline, then 1 month after surgery (M1), then 3 months after (M3)
Ran from Jan 2018 to primary completion in Dec 2023, 70 months.
Of 19 observational studies under Epiretinal Membrane, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 70. This study's 70 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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