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Internal Limiting Membrane and Macular Hole

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ClinicalTrials.gov Identifier: NCT03799575
Recruitment Status : Recruiting
First Posted : January 10, 2019
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Mun Yueh de Faria, Hospital de Santa Maria, Portugal

Brief Summary:
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.

Condition or disease Intervention/treatment
C11.768.740 Behavioral: Transmission Electron Microscopy analysis

Detailed Description:

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.


Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Morphology of Internal Limiting Membrane Peeled on Macular Hole Surgery
Actual Study Start Date : January 2, 2019
Estimated Primary Completion Date : July 2, 2019
Estimated Study Completion Date : July 2, 2019

Group/Cohort Intervention/treatment
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.
Behavioral: 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.
Behavioral: Transmission Electron Microscopy analysis
Morphology of two vitreal side of Internal Limiting Membrane in contact




Primary Outcome Measures :
  1. Fibrosis in vitreal sides of Internal Limiting Membranes [ Time Frame: 12 months ]
    Fibrilliary process between two vitreal sides of Internal Limiting Membranes in contact, after incubation in enriched medium


Biospecimen Retention:   Samples Without DNA
Internal Limiting membrane


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

  1. Full Thickness Macular Hole
  2. Male or female aged 18 years or older
  3. Visual symptoms due to IMH
  4. Intraocular pressure inferior to 21 mmHG
  5. Signed informed consent form
Criteria

Inclusion Criteria:

  • All macular holes were staged based on recent OCT based classification and only full thickness macular hole, grade 2 to 4 IMH are considered for study.

Exclusion Criteria:

  • Excluding criteria are maculopathy other than IMH, surgeries of recurrence of IMH, other retinal diseases, or an axial length greater than 26.0 mm. Mean follow-up will be at least 12 months after surgery.

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): NCT03799575


Contacts
Contact: Nuno P Ferreira, MD +351918503467 ngcpferreira@gmail.com
Contact: Andreia L Pinto, MSC +351969721099 andreia.lucia.pinto@gmail.com

Locations
Portugal
Hospital Santa Maria Recruiting
Lisbon, Lisboa, Portugal, 1649-035
Contact: Mun Y Faria, MD    +351966026791    munfaria1@gmail.com   
Sponsors and Collaborators
Hospital de Santa Maria, Portugal
Investigators
Principal Investigator: Mun Y Faria, MD Hospital Santa Maria, Centro Hospitalar Universitário Lisboa Norte, 1649-035 Lisboa, PT

Responsible Party: Mun Yueh de Faria, MD, Hospital de Santa Maria, Portugal
ClinicalTrials.gov Identifier: NCT03799575     History of Changes
Other Study ID Numbers: MD26339
First Posted: January 10, 2019    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Retinal Perforations
Retinal Diseases
Eye Diseases