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" Sweeper " and Epiretinal Membrane Surgery (SWEEPING)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03350607
Recruitment Status : Unknown
Verified November 2017 by Nantes University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : November 22, 2017
Last Update Posted : November 22, 2017
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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.


Condition or disease Intervention/treatment
Epiretinal Membrane Other: Non interventional study

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.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Prospective Monocentric Study Evaluating "Sweeper" Use During Epiretinal Membrane Surgery
Estimated Study Start Date : November 27, 2017
Estimated Primary Completion Date : May 26, 2019
Estimated Study Completion Date : August 26, 2019

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


Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Efficacy of sweeper mesured by number of forceps uses if sweeper is inefficient [ Time Frame: Day of surgery ]
  2. 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) ]
  3. 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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Criteria

Inclusion Criteria:

  • consent,
  • adult patient,
  • Epiretinal membrane

Exclusion Criteria:

  • perimetry impossible

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03350607


Contacts
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Contact: Jean-Baptiste Ducloyer, Dr 02 40 08 36 56 jeanbaptiste.ducloyer@chu-nantes.fr
Contact: Michel Weber, Pr michel.weber@chu-nantes.fr

Sponsors and Collaborators
Nantes University Hospital
Investigators
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Principal Investigator: Jean-Baptiste Ducloyer, Dr Nantes University Hospital

Publications:
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03350607    
Other Study ID Numbers: RC17_0295
First Posted: November 22, 2017    Key Record Dates
Last Update Posted: November 22, 2017
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nantes University Hospital:
Epiretinal membrane, sweeper, forceps, microperimetry
Additional relevant MeSH terms:
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Epiretinal Membrane
Retinal Diseases
Eye Diseases