Internal Limiting Membrane and Macular Hole

C11.768.740 Clinical Trial

Official title:

Morphology of Internal Limiting Membrane Peeled on Macular Hole Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03799575
• Other study ID #: MD26339
• Status: Recruiting
• Start date: January 2, 2019
• Est. completion date: July 2, 2019

Study information

• Verified date: January 2019
• Source: Hospital de Santa Maria, Portugal
• Contact: Nuno P Ferreira, MD
• Phone: +351918503467
• Email: ngcpferreira[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: July 2, 2019
• Est. primary completion date: July 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• C11.768.740
• Retinal Perforations

Intervention

Behavioral:
• Transmission Electron Microscopy analysis
Morphology of two vitreal side of Internal Limiting Membrane in contact

Locations

Country	Name	City	State
Portugal	Hospital Santa Maria	Lisbon	Lisboa

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Santa Maria, Portugal

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months