C11.768.740NCT03799575
Internal Limiting Membrane and Macular Hole
An observational study of C11.768.740, run by Hospital de Santa Maria, Portugal at 1 site in Portugal.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- C11.768.740
- What is being tested?
- Transmission Electron Microscopy analysis
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 10 participants
- Where
- 1 sitePortugal
- Study dates
- 2 Jan 2019to 2 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Hospital Santa Maria
Lisbon, Lisbon District, 1649-035
Mun Y Faria, MD, +351966026791, munfaria1@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- C11.768.740
- Being tested
- Transmission Electron Microscopy analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transmission Electron Microscopy analysisBehavioural
Morphology of two vitreal side of Internal Limiting Membrane in contact
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Transmission Electron Microscopy 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. Receives: Behavioral: Transmission Electron Microscopy analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start2 Jan 2019
- Primary completion2 Jul 2019 (estimated)
- Study completion2 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for C11.768.740Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Santa Maria, Portugal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mun Yueh de Faria, Hospital de Santa Maria, Portugal
- Investigators
- Mun Y Faria, MD, Principal investigator, Hospital Santa Maria, Centro Hospitalar Universitário Lisboa Norte, 1649-035 Lisboa, PT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03799575
- Sponsor's protocol ID
- MD26339
- Status last verified
- Jan 2019
- First submitted
- 8 Jan 2019
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31191990
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphology of Internal Limiting Membrane Peeled on Macular Hole Surgery
- ClinicalTrials.gov ID
- NCT03799575
- Acronym / sponsor ID
- MD26339
- Conditions
- C11.768.740
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hospital de Santa Maria, PortugalUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 2 Jul 2019 (estimated)
- Study completion
- 2 Jul 2019 (estimated)
- First posted
- 10 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | Behavioral: Transmission Electron Microscopy analysisTwo 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 | – | Behavioral: Transmission Electron Microscopy analysisGroup 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transmission Electron Microscopy analysisMorphology of two vitreal side of Internal Limiting Membrane in contact | Behavioural | A, B |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
- Derived from this study: PubMed 31191990Faria 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mun Y Faria, MD principal investigator
Hospital Santa Maria, Centro Hospitalar Universitário Lisboa Norte, 1649-035 Lisboa, PT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of C11.768.740, run by Hospital de Santa Maria, Portugal at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nuno P Ferreira, MD (+351918503467, ngcpferreira@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibrosis in vitreal sides of Internal Limiting Membranes (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03799575, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2019.