Internal Limiting Membrane and Macular Hole
Morphology of Internal Limiting Membrane Peeled on Macular Hole Surgery
1 other identifier
observational
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 2, 2019
CompletedFirst Submitted
Initial submission to the registry
January 8, 2019
CompletedFirst Posted
Study publicly available on registry
January 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 2, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 2, 2019
CompletedJanuary 10, 2019
January 1, 2019
6 months
January 8, 2019
January 8, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
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.
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.
Interventions
Morphology of two vitreal side of Internal Limiting Membrane in contact
Eligibility Criteria
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
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Santa Maria
Lisbon, Lisbon District, 1649-035, Portugal
Related Publications (1)
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.
PMID: 31191990DERIVED
Biospecimen
Internal Limiting membrane
Study Officials
- PRINCIPAL INVESTIGATOR
Mun Y Faria, MD
Hospital Santa Maria, Centro Hospitalar Universitário Lisboa Norte, 1649-035 Lisboa, PT
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
January 8, 2019
First Posted
January 10, 2019
Study Start
January 2, 2019
Primary Completion
July 2, 2019
Study Completion
July 2, 2019
Last Updated
January 10, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share