An observational study in C11.768.740, sponsored by Hospital de Santa Maria, Portugal. Status unknown at 1 site in Portugal. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-01-10.
Sponsored by Hospital de Santa Maria, Portugal · Observational
Observational study of Internal Limiting Membrane peeled in macular Hole surgery and studied by Transmission electronic Microscopy (TEM) and Optical Coherence Tomography (OCT) findings in closed holes.
A non-randomized prospective study of eyes with MH willing to have surgery at the Department of Ophthalmology of Santa Maria Hospital, Lisbon.
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.
Hospital de Santa Maria, Portugal is the lead sponsor of 10 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
A non-randomized prospective study of eyes with MH willing to have surgery at the Department of Ophthalmology of Santa Maria Hospital, Lisbon.
Inclusion criteria
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Exclusion Criteria:
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.
Behavioral: Transmission Electron Microscopy analysis
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.
Behavioral: Transmission Electron Microscopy analysis
Morphology of two vitreal side of Internal Limiting Membrane in contact
Fibrosis in vitreal sides of Internal Limiting Membranes
Fibrilliary process between two vitreal sides of Internal Limiting Membranes in contact, after incubation in enriched medium
Time frame: 12 months
Plan to share: No
This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Hospital de Santa Maria, Portugal