Vitreoretinal DetachmentNCT04802889
Microarchitecture of Vitreoretinal Contact
A study testing scanning electron microscopy in people with Vitreoretinal Detachment and Vitreo-Retinal Adhesion, run by The S.N. Fyodorov Eye Microsurgery State Institution at 1 site in Russia.
Trial summary
Investigation of the vitreoretinal contact microarchitecture in the macular and paramacular zones of the human retina. Read more about this study
- Who is it for?
- Ages 35 to 45 years
- Conditions the study is for
- Vitreoretinal Detachment, Vitreo-Retinal Adhesion
- What is being tested?
- scanning electron microscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jan 2008to 31 Dec 2020
- Phase
- Interventional
- 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 35 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- eyes from donors without concomitant multiple organ pathology and ophthalmic pathology
Who cannot join
- eye injury, age over 45 years, concomitant multiple organ pathology, previous eye diseases
Trial locations and contacts
1 site in 1 country.
About this study
Investigation of the vitreoretinal contact microarchitecture in the macular and paramacular zones of the human retina.
Read the detailed description
Purpose: to study the features of the macular ILM, to study the features of the preretinal structures of the vitreous body of the Central retinal region, morphofunctional features of preretinal hyalocytes, and the mechanism of vitreoretinal adhesion.
Study Protocol: examination of donor human eyes obtained from an eye Bank after sampling material for corneal transplantation.
Research method: scanning electron microscopy (SEM) of the central retina (macular and paramacular zone): ILM, preretinal vitreous.
Scientific hypothesis: vitreoretinal adhesion is provided not by laminin and fibronectin, but by the interweaving of vitreous collagen fibers between the epiretinal vitreous (more firmly fixed to the retinal surface) and the cortical vitreous.
Expected results: determination of ILM thickness in the macular zone, microanatomy of preretinal vitreous strutcures, and possible mechanism of vitreoretinal adhesion, establishing the possibility of intravital synthesis of collagen fibers synthesis in the adult vitreous.
- Conditions
- Vitreoretinal Detachment, Vitreo-Retinal Adhesion
- Being tested
- scanning electron microscopy
- Keywords
- internal limiting membrane, human vitreous, vitreomacular adhesion, vitreoretinal contact, vitreoretinal interface, hyalocytes, collagen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
scanning electron microscopyOther
scanning electron microscopy of the сentral retina and preretinal structures
| Study group | Role | What they receive |
|---|---|---|
| cadaver eyes | Experimental | The Central region of the retina and preretinal structures of cadaver eyes are examined Receives: Other: scanning electron microscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the ILM thickness in the macular zone (foveola)
the ILM thickness in the macular zone (foveola) in mkm by scanning electron microscopy data
Measured: within 3 days after receiving the cadaver eyes
superficial microstructure of ILM
by scanning electron microscopy data
Measured: within 3 days after receiving the cadaver eyes
features of the structural microarchitecture of the preretinal vitreous in the macular zone
by scanning electron microscopy data
Measured: within 3 days after receiving the cadaver eyes
morphofunctional features of preretinal hyalocytes.
by scanning electron microscopy data
Measured: within 3 days after receiving the cadaver eyes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start1 Jan 2008
- Primary completion1 Jan 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitreoretinal DetachmentStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- The S.N. Fyodorov Eye Microsurgery State Institution
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Lyskin Pavel Vladimirovich, MD, PhD, The S.N. Fyodorov Eye Microsurgery State Institution
- Investigators
- Pavel V Lyskin, PhD, Principal investigator, The S.N. Fyodorov Eye Microsurgery State Institution
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04802889
- Sponsor's protocol ID
- 124576
- Status last verified
- Mar 2021
- First submitted
- 6 Dec 2020
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microarchitecture of Vitreoretinal Contact
- ClinicalTrials.gov ID
- NCT04802889
- Acronym / sponsor ID
- 124576
- Conditions
- Vitreoretinal Detachment, Vitreo-Retinal Adhesion
- Keywords
- internal limiting membrane, human vitreous, vitreomacular adhesion, vitreoretinal contact, vitreoretinal interface, hyalocytes, collagen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The S.N. Fyodorov Eye Microsurgery State InstitutionOther government
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 17 Mar 2021 (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.
Investigation of the vitreoretinal contact microarchitecture in the macular and paramacular zones of the human retina.
Detailed description
Purpose: to study the features of the macular ILM, to study the features of the preretinal structures of the vitreous body of the Central retinal region, morphofunctional features of preretinal hyalocytes, and the mechanism of vitreoretinal adhesion.
Study Protocol: examination of donor human eyes obtained from an eye Bank after sampling material for corneal transplantation.
Research method: scanning electron microscopy (SEM) of the central retina (macular and paramacular zone): ILM, preretinal vitreous.
Scientific hypothesis: vitreoretinal adhesion is provided not by laminin and fibronectin, but by the interweaving of vitreous collagen fibers between the epiretinal vitreous (more firmly fixed to the retinal surface) and the cortical vitreous.
Expected results: determination of ILM thickness in the macular zone, microanatomy of preretinal vitreous strutcures, and possible mechanism of vitreoretinal adhesion, establishing the possibility of intravital synthesis of collagen fibers synthesis in the adult vitreous.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cadaver eyes | Experimental | Other: scanning electron microscopyThe Central region of the retina and preretinal structures of cadaver eyes are examined |
Who may qualify
- Ages
- 35 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- eyes from donors without concomitant multiple organ pathology and ophthalmic pathology
Key exclusion criteria (1 listed)
- eye injury, age over 45 years, concomitant multiple organ pathology, previous eye diseases
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 |
|---|---|---|
| scanning electron microscopyscanning electron microscopy of the сentral retina and preretinal structures | Other | cadaver eyes |
Primary outcome
the ILM thickness in the macular zone (foveola)
Time frame: within 3 days after receiving the cadaver eyes
the ILM thickness in the macular zone (foveola) in mkm by scanning electron microscopy data
superficial microstructure of ILM
Time frame: within 3 days after receiving the cadaver eyes
by scanning electron microscopy data
features of the structural microarchitecture of the preretinal vitreous in the macular zone
Time frame: within 3 days after receiving the cadaver eyes
by scanning electron microscopy data
morphofunctional features of preretinal hyalocytes.
Time frame: within 3 days after receiving the cadaver eyes
by scanning electron microscopy data
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Microanatomy of vitreoretinal interactions in macular and paramacular areas (article DOI: 10.17816/KMJ2019-595)Link provided by the sponsor.
- Microanatomy of Internal Limiting Membrane (article)Link provided by the sponsor.
- Cellular Microanatomy of Vitreoretinal Interface. Morphofunctional Identification of Epiretinal Vitreous Cells. Collagen Synthesis in Adult Human Vitreous (article)Link provided by the sponsor.
- New Data of Mechanism in Vitreoretinal Adhesion and Posterior Vitreous Detachment in Humans (article)Link provided by the sponsor.
- Antithesis to the thesis about fibronectin and laminin as the main components providing vitreoretinal adhesion (article)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Pavel V Lyskin, PhD principal investigator
The S.N. Fyodorov Eye Microsurgery State Institution
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing scanning electron microscopy in people with Vitreoretinal Detachment and Vitreo-Retinal Adhesion, run by The S.N. Fyodorov Eye Microsurgery State Institution at 1 site in Russia.
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: finished, as of the sponsor's last update on 17 Mar 2021. 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 Russia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the ILM thickness in the macular zone (foveola) (time frame: within 3 days after receiving the cadaver eyes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2021.