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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04802889
Other study ID # 124576
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2008
Est. completion date December 31, 2020

Study information

Verified date March 2021
Source The S.N. Fyodorov Eye Microsurgery State Institution
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Investigation of the vitreoretinal contact microarchitecture in the macular and paramacular zones of the human retina.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date December 31, 2020
Est. primary completion date January 1, 2020
Accepts healthy volunteers No
Gender All
Age group 35 Years to 45 Years
Eligibility 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 Design


Intervention

Other:
scanning electron microscopy
scanning electron microscopy of the ?entral retina and preretinal structures

Locations

Country Name City State
Russian Federation S.N. Fedorov Nmrc "Mntk "Eye Microsurgery" Moscow

Sponsors (1)

Lead Sponsor Collaborator
The S.N. Fyodorov Eye Microsurgery State Institution

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary the ILM thickness in the macular zone (foveola) the ILM thickness in the macular zone (foveola) in mkm by scanning electron microscopy data within 3 days after receiving the cadaver eyes
Primary superficial microstructure of ILM by scanning electron microscopy data within 3 days after receiving the cadaver eyes
Primary features of the structural microarchitecture of the preretinal vitreous in the macular zone by scanning electron microscopy data within 3 days after receiving the cadaver eyes
Primary morphofunctional features of preretinal hyalocytes. by scanning electron microscopy data within 3 days after receiving the cadaver eyes