Microarchitecture of Vitreoretinal Contact

March 15, 2021 updated by: Lyskin Pavel Vladimirovich, MD, PhD, The S.N. Fyodorov Eye Microsurgery State Institution
Investigation of the vitreoretinal contact microarchitecture in the macular and paramacular zones of the human retina.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 127486
        • S.N. Fedorov Nmrc "Mntk "Eye Microsurgery"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • eyes from donors without concomitant multiple organ pathology and ophthalmic pathology

Exclusion Criteria:

  • eye injury, age over 45 years, concomitant multiple organ pathology, previous eye diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cadaver eyes
The Central region of the retina and preretinal structures of cadaver eyes are examined
Other: scanning electron microscopy
scanning electron microscopy of the сentral retina and preretinal structures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
within 3 days after receiving the cadaver eyes
superficial microstructure of ILM
Time Frame: within 3 days after receiving the cadaver eyes
by scanning electron microscopy data
within 3 days after receiving the cadaver eyes
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
within 3 days after receiving the cadaver eyes
morphofunctional features of preretinal hyalocytes.
Time Frame: within 3 days after receiving the cadaver eyes
by scanning electron microscopy data
within 3 days after receiving the cadaver eyes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The S.N. Fyodorov Eye Microsurgery State Institution

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2008

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

December 6, 2020

First Submitted That Met QC Criteria

March 15, 2021

First Posted (Actual)

March 17, 2021

Study Record Updates

Last Update Posted (Actual)

March 17, 2021

Last Update Submitted That Met QC Criteria

March 15, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 124576

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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