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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UNKNOWN
10 participants
OBSERVATIONAL
2019-01-02
2019-07-02
Brief Summary
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Detailed Description
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Surgeries are performed under local or general anesthesia, pars plana vitrectomy with internal limiting membrane peeling, fluid gas exchange and face down position.
Two samples of discarded ILM peeled in Macular hole surgery is studied in Laboratory.
Laboratory Analysis Two samples of ILM per patient are harvested, one will be immediately fixed and submitted to Optic Microscopy (OM) and Transmission Electron Microscopy (TEM) analysis, and another sample will be incubated in enriched medium 199 (Gibco) for 20 minutes at room temperature, after which it will also be fixed and submitted to OM and TEM analysis. Both samples from same patient will follow the protocol available at dx.doi.org/10.17504/protocols.io.qjiduke.
Image acquisition Six electron-micrographs will be acquired for each fragment, using a Hitachi H-7000 electron microscope equipped with a megaview III digital camera. Fields of interest will be randomly selected, and acquisition of 15,000x magnification images.
Histology and immunohistochemistry ILM samples will be stained with anti-GFAP antibody (anti-glial fibrillary acidic protein), to detect this protein in glial cells.
Results:
Only successful macular hole closure will be considered, BCVA will be compared before and after surgery and related to OCT findings. ILM findings in TEM analysis will be compared with and without enriched medium.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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A
Two samples of ILM per patient are harvested, group A will be immediately fixed and submitted to Optic Microscopy (OM) and Transmission Electron Microscopy (TEM) analysis, and another sample will be incubated in enriched medium 199 (Gibco) for 20 minutes at room temperature, after which it will also be fixed and submitted to OM and TEM analysis.
Transmission Electron Microscopy analysis
Morphology of two vitreal side of Internal Limiting Membrane in contact
B
Group B sample will be incubated in enriched medium 199 (Gibco) for 20 minutes at room temperature, after which it will also be fixed and submitted to OM and TEM analysis.
Transmission Electron Microscopy analysis
Morphology of two vitreal side of Internal Limiting Membrane in contact
Interventions
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Transmission Electron Microscopy analysis
Morphology of two vitreal side of Internal Limiting Membrane in contact
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
90 Years
ALL
No
Sponsors
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Hospital de Santa Maria, Portugal
OTHER
Responsible Party
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Mun Yueh de Faria
MD
Principal Investigators
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Mun Y Faria, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Santa Maria, Centro Hospitalar Universitário Lisboa Norte, 1649-035 Lisboa, PT
Locations
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Hospital Santa Maria
Lisbon, Lisbon District, Portugal
Countries
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Central Contacts
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Facility Contacts
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References
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Faria MY, Sousa DC, Almeida BC, Pinto AL, Ferreira NP. Morphology of Peeled Internal Limiting Membrane in Macular Hole Surgery. J Ophthalmol. 2019 May 2;2019:1345683. doi: 10.1155/2019/1345683. eCollection 2019.
Other Identifiers
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MD26339
Identifier Type: -
Identifier Source: org_study_id
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