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Foveal Sparing of the ILM

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ClinicalTrials.gov Identifier: NCT03488576
Recruitment Status : Completed
First Posted : April 5, 2018
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
Francesco Semeraro, Università degli Studi di Brescia

Study Description
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Brief Summary:
To compare the retinal sensitivity of complete internal limiting membrane (ILM) peeling versus foveal sparing ILM peeling during vitrectomy for epiretinal membrane or macular hole.

Condition or disease Intervention/treatment Phase
Retinal Sensitivity Procedure: Complete Macular Peeling Procedure: Macular Peeling with Foveal Sparing Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This was a prospective study including ninety-one eyes of 190 phakic patients scheduled to undergo vitrectomy for idiopathic macular pucker or macular hole, from July 2014 to December 2016. Patients were randomized in a 1:1 ratio to complete peeling of the ILM (CP group) or foveal sparing (FS group).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Macular Peeling With Foveal Sparing of the Internal Limiting Membrane: A Pilot Study
Actual Study Start Date : July 1, 2014
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Complete Peeling
Patient underwent scheduled vitrectomy for epiretinal membrane or macular hole with complete macular peeling of the internal limiting membrane.
 Procedure: Complete Macular Peeling
A complete peeling of the internal limiting membrane was performed
Experimental: Foveal Sparing
Patient underwent scheduled vitrectomy for epiretinal membrane or macular hole with partial peeling the internal limiting membrane (foveal sparing).
 Procedure: Macular Peeling with Foveal Sparing
A partial peeling of the internal limiting membrane was performed, sparing the fovea.


Outcome Measures
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Primary Outcome Measures :
  1. Retinal Sensitivity (dB) [ Time Frame: 12-month ]
    Microperimetry was done to assess macular sensitivity

  2. Visual Acuity (LogMAR) [ Time Frame: 12-month ]
    ETDRS charts were used to assess best corrected visual acuity

  3. Central Retinal Thickness (microns) [ Time Frame: 12-month ]
    Optical Coherence Tomography will be used to assess central retinal thickness


Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • provision of written informed consent
  • age > 60 years
  • presence of idiopathic macular pucker or macular hole documented by OCT

Exclusion Criteria:

  • any prior intraocular surgery
  • pathologic myopia (> 7 diopters)
  • age related macular degeneration
  • glaucoma and diabetic retinopathy or any other retinal vascular disease
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Francesco Semeraro, Francesco Semeraro; MD, Associate Professor, Università degli Studi di Brescia
ClinicalTrials.gov Identifier: NCT03488576    
Other Study ID Numbers: Vitreo003
First Posted: April 5, 2018    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases