" Sweeper " and Epiretinal Membrane Surgery

Epiretinal Membrane Clinical Trial

— SWEEPING  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03350607
• Other study ID #: RC17_0295
• Status: Recruiting
• Start date: January 24, 2018
• Est. completion date: October 24, 2025

Study information

• Verified date: August 2023
• Source: Nantes University Hospital
• Contact: Jean-Baptiste Ducloyer, Dr
• Phone: 02 40 08 36 56
• Email: jeanbaptiste.ducloyer[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 24, 2025
• Est. primary completion date: July 24, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• consent,

• adult patient,

• Epiretinal membrane

Exclusion Criteria:

• perimetry impossible

Related Conditions & MeSH terms

• Epiretinal Membrane

Intervention

Other:
• Non interventional study
Non interventional study (collect of data)

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

References & Publications (4)

Azuma K, Ueta T, Eguchi S, Aihara M. EFFECTS OF INTERNAL LIMITING MEMBRANE PEELING COMBINED WITH REMOVAL OF IDIOPATHIC EPIRETINAL MEMBRANE: A Systematic Review of Literature and Meta-Analysis. Retina. 2017 Oct;37(10):1813-1819. doi: 10.1097/IAE.0000000000001537. — View Citation

Deltour JB, Grimbert P, Masse H, Lebreton O, Weber M. DETRIMENTAL EFFECTS OF ACTIVE INTERNAL LIMITING MEMBRANE PEELING DURING EPIRETINAL MEMBRANE SURGERY: Microperimetric Analysis. Retina. 2017 Mar;37(3):544-552. doi: 10.1097/IAE.0000000000001179. — View Citation

Fang XL, Tong Y, Zhou YL, Zhao PQ, Wang ZY. Internal limiting membrane peeling or not: a systematic review and meta-analysis of idiopathic macular pucker surgery. Br J Ophthalmol. 2017 Nov;101(11):1535-1541. doi: 10.1136/bjophthalmol-2016-309768. Epub 2017 Mar 17. — View Citation

Ripandelli G, Scarinci F, Piaggi P, Guidi G, Pileri M, Cupo G, Sartini MS, Parisi V, Baldanzellu S, Giusti C, Nardi M, Stirpe M, Lazzeri S. Macular pucker: to peel or not to peel the internal limiting membrane? A microperimetric response. Retina. 2015 Mar;35(3):498-507. doi: 10.1097/IAE.0000000000000330. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference of number and depth of micro scotoma before and after epiretinal membrane (ERM) surgery with sweeper		microperimetry at baseline, then 1 month after surgery (M1), then 3 months after (M3)
Secondary	Efficacy of sweeper mesured by number of forceps uses if sweeper is inefficient		Day of surgery
Secondary	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)
Secondary	Optical coherence tomography (OCT) improvement after surgery measured by OCT morphometry		at baseline, then 1 month after surgery (M1), then 3 months after (M3)