CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 9 enrolled
Drug / intervention
Non interventional studyother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03350607
NCT03350607N/ACompleted

Observational Prospective Monocentric Study Evaluating "Sweeper" Use During Epiretinal Membrane Surgery

Nantes University Hospital·observational·Posted Nov 22, 2017·Updated Oct 9, 2024

In Brief

An observational study evaluating Non interventional study for Epiretinal Membrane. Completed, enrolled 9 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedNov 22, 2017
Enrollment StartJan 24, 2018
Primary CompletionDec 13, 2023
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 8.6 years ago

Interventions

Non interventional studyother

Non interventional study (collect of data)