Internal Limiting Membrane and Macular Hole

Morphology of Internal Limiting Membrane Peeled on Macular Hole Surgery

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.

Study Overview

• Status: Unknown
• Conditions: C11.768.740
• Intervention / Treatment: 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
• Enrollment (Anticipated): 10

Contacts and Locations

Study Locations

• Portugal
  • Lisboa
    • Lisbon, Lisboa, Portugal, 1649-035
      • Recruiting
      • Hospital Santa Maria
      • Contact: Mun Y Faria, MD; Phone Number: +351966026791; Email: munfaria1@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hospital de Santa Maria, Portugal
• Investigators: Principal Investigator: Mun Y Faria, MD, Hospital Santa Maria, Centro Hospitalar Universitário Lisboa Norte, 1649-035 Lisboa, PT

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2019
• Primary Completion (Anticipated): July 2, 2019
• Study Completion (Anticipated): July 2, 2019

Study Registration Dates

• First Submitted: January 8, 2019
• First Submitted That Met QC Criteria: January 8, 2019
• First Posted (Actual): January 10, 2019

Study Record Updates

• Last Update Posted (Actual): January 10, 2019
• Last Update Submitted That Met QC Criteria: January 8, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Perforations
• Other Study ID Numbers: MD26339

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No