EpiRetinal Membrane Peeling and Internal Limiting Membrane
NCT ID: NCT04802265
Last Updated: 2023-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
10 participants
OBSERVATIONAL
2021-05-21
2021-08-01
Brief Summary
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Detailed Description
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Each patient undergo the same procedure : first of all pars plana vitrectomy, then internal limiting membrane peeling is performed and facilitated by the use of dye, which aids in better visualization of the ILM.
If the ILM is removed in same time : the patient is ranked in the "ILM peeling" group If the ILM is not removed : the patient is ranked in the "non ILM peeling" group.
If the ILM is partially removed, the patient is not enrolled.
The outcomes are recorded for 6 months : at baseline, day 15, 1, 3 and 6 months.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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ILM peeling
ILM is peeled during epiretinal membrane surgery
Epiretinal membrane surgery
The surgery consists of a 23 or 25-gauge pars plana vitrectomy (PPV). The surgery was performed peri-bulbar anesthesia and could be combined with phacoemulsification.
An intraocular dye is used to well visualized and facilitate ERM peeling. The ILM is not actively peeled. A search for iatrogenic breaks is performed towards the end of the procedure. Areas suspicious for breaks are treated with cryotherapy or peripheral endolaser.
without ILM peeling
ILM is not peeled during epiretinal membrane surgery
Epiretinal membrane surgery
The surgery consists of a 23 or 25-gauge pars plana vitrectomy (PPV). The surgery was performed peri-bulbar anesthesia and could be combined with phacoemulsification.
An intraocular dye is used to well visualized and facilitate ERM peeling. The ILM is not actively peeled. A search for iatrogenic breaks is performed towards the end of the procedure. Areas suspicious for breaks are treated with cryotherapy or peripheral endolaser.
Interventions
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Epiretinal membrane surgery
The surgery consists of a 23 or 25-gauge pars plana vitrectomy (PPV). The surgery was performed peri-bulbar anesthesia and could be combined with phacoemulsification.
An intraocular dye is used to well visualized and facilitate ERM peeling. The ILM is not actively peeled. A search for iatrogenic breaks is performed towards the end of the procedure. Areas suspicious for breaks are treated with cryotherapy or peripheral endolaser.
Eligibility Criteria
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Inclusion Criteria
* diagnosed and treated surgically
Exclusion Criteria
* ocular trauma,
* central veinous occlusion,
* intra-ocular tumor, total retinal detachment,
* central visual field loss in glaucomatous patients
18 Years
99 Years
ALL
No
Sponsors
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University Hospital, Clermont-Ferrand
OTHER
Responsible Party
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Principal Investigators
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Isabelle Sillaire
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Clermont-Ferrand
Locations
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CHU Clermont-Ferrand
Clermont-Ferrand, AURA, France
Countries
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Other Identifiers
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2021-A00071-40
Identifier Type: OTHER
Identifier Source: secondary_id
RBHP 2021 SILLAIRE
Identifier Type: -
Identifier Source: org_study_id
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