" Sweeper " and Epiretinal Membrane Surgery

NCT03350607 | Completed

• 1 other identifier: RC17_0295
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Epiretinal Membrane

Keywords

Epiretinal membrane, sweeper, forceps, microperimetry

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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)

Interventions

Non interventional study OTHER

Non interventional study (collect of data)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• consent,
• adult patient,
• Epiretinal membrane

You may not qualify if:

• perimetry impossible

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital

Nantes, Loire-Atlantique, 44000, France

Location

Related 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.

  PMID: 28207608 BACKGROUND

• 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.

  PMID: 28314834 BACKGROUND

• 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.

  PMID: 25158943 BACKGROUND

• 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.

  PMID: 27429376 BACKGROUND

MeSH Terms

Conditions

Epiretinal Membrane

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Officials

• Jean-Baptiste Ducloyer, Dr

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2017
• First Posted: November 22, 2017
• Study Start: January 24, 2018
• Primary Completion: December 13, 2023
• Study Completion: December 13, 2023
• Last Updated: October 9, 2024

Record last verified: 2024-10

Locations

FR (1)