Microarchitecture of Vitreoretinal Contact

• Sponsor: The S.N. Fyodorov Eye Microsurgery State Institution (Other)
• Overall Status: Completed
• CT.gov ID: NCT04802889
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Actual Duration (Months): 156
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Vitreoretinal Detachment; Vitreo-Retinal Adhesion	Other: scanning electron microscopy	N/A

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

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Microarchitecture of Vitreoretinal Contact
• Actual Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Jan 1, 2020
• Actual Study Completion Date: Dec 31, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. the ILM thickness in the macular zone (foveola) [within 3 days after receiving the cadaver eyes]

   the ILM thickness in the macular zone (foveola) in mkm by scanning electron microscopy data

2. superficial microstructure of ILM [within 3 days after receiving the cadaver eyes]

   by scanning electron microscopy data

3. features of the structural microarchitecture of the preretinal vitreous in the macular zone [within 3 days after receiving the cadaver eyes]

   by scanning electron microscopy data

4. morphofunctional features of preretinal hyalocytes. [within 3 days after receiving the cadaver eyes]

   by scanning electron microscopy data

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	S.N. Fedorov Nmrc "Mntk "Eye Microsurgery"	Moscow		Russian Federation	127486

Sponsors and Collaborators

• The S.N. Fyodorov Eye Microsurgery State Institution

Investigators

• Principal Investigator: Pavel V Lyskin, PhD, The S.N. Fyodorov Eye Microsurgery State Institution

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Microanatomy of vitreoretinal interactions in macular and paramacular areas (article DOI: 10.17816/KMJ2019-595)
• Microanatomy of Internal Limiting Membrane (article)
• Cellular Microanatomy of Vitreoretinal Interface. Morphofunctional Identification of Epiretinal Vitreous Cells. Collagen Synthesis in Adult Human Vitreous (article)
• New Data of Mechanism in Vitreoretinal Adhesion and Posterior Vitreous Detachment in Humans (article)
• Antithesis to the thesis about fibronectin and laminin as the main components providing vitreoretinal adhesion (article)

Publications

None provided.

• Responsible Party: Lyskin Pavel Vladimirovich, MD, PhD, MD, PhD, ophthalmosurgeon, The S.N. Fyodorov Eye Microsurgery State Institution
• ClinicalTrials.gov Identifier: NCT04802889
• Other Study ID Numbers: 124576
• First Posted: Mar 17, 2021
• Last Update Posted: Mar 17, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Lyskin Pavel Vladimirovich, MD, PhD, MD, PhD, ophthalmosurgeon, The S.N. Fyodorov Eye Microsurgery State Institution: internal limiting membrane; human vitreous; vitreomacular adhesion; vitreoretinal contact; vitreoretinal interface; hyalocytes; collagen
• Additional relevant MeSH terms: Tissue Adhesions

Study Results

No Results Posted as of Mar 17, 2021