Observational Prospective Monocentric Study Evaluating "Sweeper" Use During Epiretinal Membrane Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Epiretinal Membrane
- Sponsor
- Nantes University Hospital
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Difference of number and depth of micro scotoma before and after epiretinal membrane (ERM) surgery with sweeper
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •adult patient,
- •Epiretinal membrane
Exclusion Criteria
- •perimetry impossible
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- Efficacy of sweeper mesured by number of forceps uses if sweeper is inefficient(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(at baseline, then 1 month after surgery (M1), then 3 months after (M3))
- Optical coherence tomography (OCT) improvement after surgery measured by OCT morphometry(at baseline, then 1 month after surgery (M1), then 3 months after (M3))