NCT04802889

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
12 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2020

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 17, 2021

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2021

Enrollment Period

12 years

First QC Date

December 6, 2020

Last Update Submit

March 15, 2021

Conditions

Keywords

internal limiting membranehuman vitreousvitreomacular adhesionvitreoretinal contactvitreoretinal interfacehyalocytescollagen

Outcome Measures

Primary Outcomes (4)

  • 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

  • superficial microstructure of ILM

    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

    by scanning electron microscopy data

    within 3 days after receiving the cadaver eyes

  • morphofunctional features of preretinal hyalocytes.

    by scanning electron microscopy data

    within 3 days after receiving the cadaver eyes

Study Arms (1)

cadaver eyes

EXPERIMENTAL

The Central region of the retina and preretinal structures of cadaver eyes are examined

Other: scanning electron microscopy

Interventions

scanning electron microscopy of the сentral retina and preretinal structures

cadaver eyes

Eligibility Criteria

Age35 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

S.N. Fedorov Nmrc "Mntk "Eye Microsurgery"

Moscow, 127486, Russia

Location

Related Links

MeSH Terms

Interventions

Microscopy, Electron, Scanning

Intervention Hierarchy (Ancestors)

Microscopy, ElectronMicroscopyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Pavel V Lyskin, PhD

    The S.N. Fyodorov Eye Microsurgery State Institution

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, ophthalmosurgeon

Study Record Dates

First Submitted

December 6, 2020

First Posted

March 17, 2021

Study Start

January 1, 2008

Primary Completion

January 1, 2020

Study Completion

December 31, 2020

Last Updated

March 17, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations